NA 422.392Recalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW SELF-DRILLING 26MM · Class 2 · Implant
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 10886982215864), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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
- Incomplete or Missing Packaging1
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.
MalfunctionMar 8, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT THERE WERE MULTIPLE MISSING SCREWS IN AN EVALUATIONS SET. SET WAS NEVER USED OR STERILIZED. TRAYS NEVER ENTERED OPERATING ROOM SUITE. MISSING SCREWS IN TRAYS WERE DISCOVERED WHEN TOTE WAS OPENED TO CHECK CONDITION OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7324324 ↗
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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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