NA SD03.161.057Recalls & reported problems
Synthes GmbH · TEMPORARY FIXATION PIN W/HXC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034700847), received between Dec 19, 2016 and Dec 20, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2016Break; Break
THE INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE A DUPLICATE OF ANOTHER COMPLAINT (B)(4). ALL EVENT DETAILS WILL BE CAPTURED WILL BE CAPTURED IN THAT COMPLAINT AND MEDWATCH REPORT MFR NUMBER 2530088-2016-10346.
Patient problems: No Code Available
MAUDE report 6191662 ↗MalfunctionDec 19, 2016Break; Break
IT WAS REPORTED THAT DURING AN ALIF (ANTERIOR LUMBAR INTERBODY FUSION) PROCEDURE AT L5-S1 FOR SPONDY ON (B)(6) 2016, THE TEMPORARY FIXATION PIN BROKE. THE SURGEON NOTED THAT PLACEMENT OF THE ANTEGRA PLATE WAS NOT STRAIGHT AND THE TEMPORARY FIXATION PIN WAS BACKED IN ORDER TO PROPERLY ALIGN THE PLATE. WHILE BACKING OUT THE TEMPORARY FIXATION PIN, THE THREADED PORTION OF THE PIN BROKE OFF FROM THE MAIN SHAFT. THE TEMPORARY FIXATION PIN BROKE INTO TWO PIECES AND BOTH PIECES WERE EASILY RETRIEVED. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE FLUOROSCOPIC IMAGES WERE TAKEN AS STANDARD FOR THE PROCEDURE AND NOT CONSIDERED AS ADDITIONAL INTERVENTION. THE IMAGES VERIFIED THAT BROKEN PIECES WERE RETRIEVED. THE SURGEON WAS SATISFIED WITH THE STABILITY OF THE CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: ANTEGRA PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6185199 ↗
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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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