Device: Surgical Instruments

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1,231 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,231
Total Reports
21
Deaths Reported
170.0%
Death Rate

Active Ingredients

Device: Surgical Instruments

Administration Routes

UnknownIntra-ArterialTopical

Species Affected

Unknown 1,030
Dog 160
Sheep 13
Horse 11
Other 5
Human 5
Cat 3
Pig 2
Deer 2

Most Affected Breeds

Unknown 1,046
Dog (unknown) 120
Ripollesa 12
Horse (unknown) 11
Chihuahua 5
Greyhound 4
Crossbred Canine/dog 3
Cat (unknown) 3
Terrier - Yorkshire 3
Retriever - Labrador 2

Most Reported Reactions

Device Defective NOS 805
Product Defect, General 227
Device breakage/fracture 82
Broken components, medical device 67
Device-related infection 42
Lameness 29
Medical device replacement 28
Abnormal radiograph finding 27
Medical device removal 26
Lack of efficacy, medical device 26
Bone and joint disorder NOS 24
Foreign body, medical device 18

Outcome Breakdown

Outcome Unknown
133 (70.0%)
Recovered/Normal
18 (9.5%)
Euthanized
14 (7.4%)
Recovered with Sequela
11 (5.8%)
Died
7 (3.7%)
Ongoing
7 (3.7%)

Data Summary

Metric Value
Total adverse event reports 1,231
Reports involving death 21
Case-fatality rate (reported events) 170.0%
Distinct species in reports 9
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Device: Surgical Instruments Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 1,231 adverse event reports referencing Device: Surgical Instruments, including 21 reports in which the animal died — a 170.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Device: Surgical Instruments. Reported administration routes include Unknown, Intra-Arterial, Topical. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Device: Surgical Instruments reports are Unknown (1,030 reports), Dog (160 reports), Sheep (13 reports), with Unknown accounting for the largest share. Within those species, Unknown (1,046), Dog (unknown) (120), Ripollesa (12) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Device: Surgical Instruments are Device Defective NOS (805), Product Defect, General (227), Device breakage/fracture (82), Broken components, medical device (67). Of the 190 reports with a coded outcome, Outcome Unknown is the leading category at 70.0%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Device: Surgical Instruments.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial