OASYS 48561039Recalls & reported problems
Stryker Corporation · ROD ROTATION FORCEPS · Class 1
All models of OASYS (60)
Data updated Oct 18, 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 07613327271447), received between Sep 13, 2016 and Sep 13, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2016Break; Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A POSTERIOR THORACIC REVISION CASE WHILE REMOVING A SCREW, THE TULIP HEAD SNAPPED OFF LEAVING THE THREAD IMPLANTED. ADDITIONALLY, WHILE REMOVING IMPLANTS, SEVERAL INSTRUMENTS WERE DAMAGED/STRIPPED OR BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5945557 ↗
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- NA 1120Advanced Neuromodulation Systems, Inc. · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- NA 365538Medtronic, Inc. · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- 3.3mm Mini-Bolt VUE 21133Monteris Medical Inc · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- Integra® Jarit® 285120Integra Lifesciences Production Corporation · INSTRUMENT, SURGICAL, NON-POWERED1 report
- V. Mueller NL1098Steris Corporation · INSTRUMENT, SURGICAL, NON-POWERED1 report
- NeuroBalloon™ 7CBD10Integra LifeSciences Switzerland Sàrl · INSTRUMENT, SURGICAL, NON-POWERED1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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