NA 04.205.055Recalls & reported problems
Synthes GmbH · 5.0MM TI CANNULATED LOCKING SCREW 55MM · Class 2 · Implant
Data updated Oct 18, 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 10886982116376), received between Jan 3, 2023 and Jan 3, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY. DURING THE SURGERY, THE LOCKING SCREW WAS TOO TIGHT AND COULD NOT BE REMOVED. THE SCREW HEAD GOT STRIPPED, SO THE SURGEON REMOVED THE OTHER SCREWS. THEN, THE SURGEON REMOVED THE LOCKING SCREW IN QUESTION WITH THE PLATE. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: LOCKING: TRAUMA. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16090440 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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