NA 04.201.028Recalls & reported problems
Synthes GmbH · 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 28MM · 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 10705034733869), received between Nov 25, 2019 and Nov 25, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
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.
InjuryNov 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING HARDWARE REMOVAL SURGERY ON (B)(6) 2019, ONE (1) TITANIUM (TI) CANCELLOUS LOCKING SCREW 32MM AND ONE (1) TITANIUM (TI) CANCELLOUS LOCKING SCREW 28MM WERE UNABLE TO BE REMOVED DUE TO THEY BEING LOCKED (COLD WELDED) INTO THE TI ANTEGRA ALIF PLATE. ORIGINALLY, THE PATIENT HAD HIP SURGERY ON (B)(6) 2019 AND WAS IMPLANTED WITH ONE PLATE AND FOUR SCREWS. ON AN UNKNOWN DATE AFTER THE INITIAL SURGERY, IT WAS FOUND OUT THAT TWO SCREWS WERE A LITTLE TOO LONG AND THE SURGEON WANTED TO SHORTEN THE SCREWS. THE SURGEON CANNOT REMOVE THE SCREW THAT WAS COLD-WELDED TO THE PLATE DESPITE NUMEROUS EFFORTS. HOWEVER, ONLY ONE SCREW WAS REMOVED AND THE OTHER ONE STAYED IN PLACE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2) THIS REPORT IS FOR ONE (1) 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 28MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Code Available
MAUDE report 9369499 ↗
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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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