OASYS 48554318Recalls & reported problems
Stryker Corporation · BONE SCREW · Class 2 · Implant
Data updated Oct 13, 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 04546540371966), received between May 18, 2016 and May 18, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Bent” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Bent1
- Break1
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2016Bent; Break; Difficult to Remove
IT WAS REPORTED THAT; THE SILVER SCREW BROKE UPON INSERTION LEAVING THE BROKEN END IN PATIENT. IT WAS REPORTED THAT THEY WERE NOT ABLE TO REMOVE IT. IT WAS ALSO REPORTED THAT THE BLUE SCREW BENT UPON INSERTION. IT WAS REPORTED THAT LOT NUMBERS UNKNOWN, ITEMS REMOVED FROM PACKAGING TO BE STERILIZED IN THE SET. IT WAS REPORTED THAT PRODUCT REACHED PATIENT; NO APPARENT HARM; PROBABLY INCONVENIENT FOR PATIENT AND/OR STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5664997 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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