NA 498.866Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034791852), received between Jun 6, 2017 and Jun 6, 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2014, THE PATIENT UNDERWENT A L5-S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WITH THE SYNTHES SYNFIX-LR DEVICE. IT WAS REPORTED THAT ACCORDING TO THE PHYSICIAN, THE PATIENT NEVER DEVELOPED A SOLID FUSION AFTER THE INITIAL SURGERY AND THAT THE PATIENT HAD RADICULAR PAIN. REPORTEDLY, PATIENT HAD RADICULOPATHY. NO ISSUES WITH THE SYNFIX-LR HARDWARE WERE REPORTED. THE SURGEON PLANNED TO PERFORM A POSTERIOR SPINAL FUSION WITH SYNTHES USS AND PERFORM A DECOMPRESSION. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. DURING THE REVISION SURGERY, THE SURGEON PLACED THE L5-S1 USS SCREWS. WHILE INSERTING THE RIGHT S1 USS SCREW (498.866), THE TOP PART OF THE SCREW THAT ENGAGES THE ¿IMPLANT HOLDER / STICK 388.61¿ BROKE OFF. THIS PIECE WAS RETRIEVED. TWO OF THE 388.61 STICKS ALSO BROKE TRYING TO GET THE SCREW OUT ¿ THE TABS THAT ENGAGE THE TOP OF THE SCREW BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS A TREMENDOUS AMOUNT OF TORQUE THAT WAS PLACED ON THE SCREW AND THE STICKS THAT CONTRIBUTED TO THE BREAKAGES. THE SURGEON THOUGHT THAT THE USS SCREW WAS HITTING ON THE SYNFIX SCREW IN S1 CONTRIBUTING TO THE HIGH TORQUE. HE THEN USED A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6614995 ↗