NA 1806-6135Recalls & reported problems
Stryker GmbH · Extraction Instrument, Lag Screw · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154403905), received between Apr 5, 2022 and Apr 5, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2022Use of Device Problem; Use of Device Problem
AS REPORTED: "WHEN USING THE REMOVAL EQUIPMENT, THE OPERATOR ENCOUNTERS DIFFICULTIES IN REMOVING THE CERVICAL SCREW. THE CERVICAL SCREW EXTRACTOR HANDLE AND SHAFT 18066135 DID NOT FIT ON THE SCREW. THE OPERATOR WAS FINALLY ABLE TO REMOVE THE MATERIAL, BUT STRESS WAS GENERATED AND THE INTERVENTION TIME WAS EXTENDED. PROCEDURE: REMOVAL OF GAMMA NAIL"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14012515 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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