NA 04.201.032Recalls & reported problems
Synthes GmbH · 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 32MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034733883), received between Oct 23, 2019 and Oct 23, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/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
- Material Twisted/Bent1
- Use of Device Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2019Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent
IT WAS FURTHER REPORTED THAT THE ORIGINAL SCREWS PLACED ON THE LEFT SIDE WAS TOO LONG AND WAS CAUSING THE PATIENT ISSUES. THE LEFT SCREW WAS REMOVED AND REPLACED WITH A SHORTER SCREW. THE SURGEON DECIDED TO REMOVE THE RIGHT SIDE SCREW AS WELL AND WAS UNABLE TO REMOVE DUE TO THE SCREW BEING COLD WELDED. THE IMPLANTS WERE NOT REMOVED AND LEFT IN THE PATIENT.
Patient problems: No Code Available
MAUDE report 9227316 ↗
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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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