NA 388.63Recalls & reported problems
Synthes GmbH · HOOK POSITIONER · Class 1
Data updated Oct 13, 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 10705034773667), received between Jul 24, 2017 and Jul 24, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2017Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THREE DEVICES MALFUNCTIONED DURING A T4-L2 SCOLIOSIS PROCEDURE ON (B)(6) 2017. DURING THE PROCEDURE, A HOOK POSITIONER HAD A CHUNK COME OUT OF THE PHENOLIC HANDLE DURING MALLETING. THE CHUNK WAS RECOVERED EASILY. LATER, A SOCKET WRENCH WITH STRAIGHT HANDLE SPLIT INTO TWO PIECES DURING MALLETING. ALL PIECES WERE RECOVERED. FINALLY, UPON FINAL TIGHTENING, THE SURGEON NOTICED THAT A TITANIUM (TI) COLLAR WITH GROOVES AT T8 LEFT WAS BROKEN TOWARD THE END OF THE PROCEDURE. THE BROKEN DEVICE WAS EASILY AND QUICKLY REMOVED AND ANOTHER COLLAR WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: TITANIUM NUT 11MM WIDTH ACROSS FLATS (PART 498.003, LOT NUMBER UNKNOWN, QUANTITY 1); 5.0MM TITANIUM SIDE-OPENING SCREW 35MM (PART 498.535, LOT NUMBER UNKNOWN, QUANTITY 1); MALLET (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOOK POSITIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6736677 ↗
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- Sklar Instruments 96-4020MSklar Corporation · HOOK, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- Centurion 66660Centurion Medical Products Corporation · HOOK, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
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- NICO BrainPath NN-8025Nico Corporation · Hook, Surgical, General & Plastic Surgery1 recall0 reports
- Sklar Instruments 96-4022MSklar Corporation · HOOK, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
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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