NA 0250080319Recalls & reported problems
Stryker Corporation · Insert, Dorsey Grasper · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327058239), received between Jul 31, 2018 and Apr 4, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE BROKEN PIECES WERE SUCCESSFULLY RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774504 ↗MalfunctionJul 31, 2018Break
IT WAS REPORTED THAT THE PIECES BROKE OFF INSIDE THE PATIENT. BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7735624 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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