NA 03.616.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034716336), received between Apr 23, 2017 and Jan 31, 2023 — classified as 6 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Material Integrity Problem; Material Integrity Problem

  THIS REPORT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274785 ↗
• MalfunctionJan 31, 2023Material Integrity Problem; Material Integrity Problem

  THIS REPORT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274783 ↗
• MalfunctionSep 15, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION ON (B)(6) 2020, FOR A L4-5 SPINAL CANAL STENOSIS, THE 1ST SLEEVE HAD CROSS-THREADING WITH A SCREW. THE SLEEVE¿S FRAGMENT GOT STUCK WITH THE COUNTERPART. FURTHERMORE, THE 2ND SLEEVE (REPLACEMENT) BROKE, TOO. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: REDUCTION SCREW (PART#: 04.634.645S, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10536527 ↗
• MalfunctionSep 15, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION ON (B)(6) 2020, FOR A L4-5 SPINAL CANAL STENOSIS, THE 1ST SLEEVE HAD CROSS-THREADING WITH A SCREW. THE SLEEVE¿S FRAGMENT GOT STUCK WITH THE COUNTERPART. FURTHERMORE, THE 2ND SLEEVE (REPLACEMENT) BROKE, TOO. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: REDUCTION SCREW (PART#: 04.634.645S, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10536459 ↗
• MalfunctionApr 23, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORT THAT DURING AN INITIAL POSTERIOR LUMBAR INTER-BODY FUSION (PLIF) PROCEDURE AT DISC LEVELS L4-L5 AND L5-S1 ON (B)(6) 2017 INVOLVING THE IMPLANTATION OF TWO (2) UNKNOWN OPAL SPACERS, EIGHT (8) UNKNOWN SCREWS AND TWO (2) UNKNOWN RODS, SEVERAL INSTRUMENT MALFUNCTIONS OCCURRED. DURING SCREW INSERTION AT UNKNOWN DISC LEVELS, TWO (2) LOCKING HOLDING SLEEVES WERE REPORTED TO HAVE STRIPPED THREADS. WHILE SURGEON WAS ATTEMPTING SPACER INSERTION THE PRONG ON THE OPAL IMPLANT HOLDER WAS DISCOVERED TO HAVE BENT. DURING ANOTHER SCREW INSERTION ATTEMPT AT AN UNKNOWN DISC LEVEL, THE STAR-DRIVE SHAFT INSTRUMENT WAS NOTED TO BE STRIPPED AND NOT WORKING CORRECTLY. ALSO, THE RATCHET T-HANDLE INSTRUMENT WOULD NOT SPIN, CAUSING INSTRUMENT TO NOT TIGHTEN DURING IMPLANT INSERTION. BACK UP INSTRUMENTS WERE AVAILABLE IN THE OPERATING ROOM. NO FRAGMENTS WERE GENERATED DURING THE REPORTED INSTRUMENT EVENTS. A FIVE (5) MINUTE SURGICAL DELAY WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES: UNKNOWN SCREWS (ITEM # UNKNOWN, LOT # UNKNOWN, QUANTITY 8). UNKNOWN OPAL SPACER (ITEM # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). UNKNOWN RODS (IT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6515055 ↗
• MalfunctionApr 23, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORT THAT DURING AN INITIAL POSTERIOR LUMBAR INTER-BODY FUSION (PLIF) PROCEDURE AT DISC LEVELS L4-L5 AND L5-S1 ON (B)(6) 2017 INVOLVING THE IMPLANTATION OF TWO (2) UNKNOWN OPAL SPACERS, EIGHT (8) UNKNOWN SCREWS AND TWO (2) UNKNOWN RODS, SEVERAL INSTRUMENT MALFUNCTIONS OCCURRED. DURING SCREW INSERTION AT UNKNOWN DISC LEVELS, TWO (2) LOCKING HOLDING SLEEVES WERE REPORTED TO HAVE STRIPPED THREADS. WHILE SURGEON WAS ATTEMPTING SPACER INSERTION THE PRONG ON THE OPAL IMPLANT HOLDER WAS DISCOVERED TO HAVE BENT. DURING ANOTHER SCREW INSERTION ATTEMPT AT AN UNKNOWN DISC LEVEL, THE STAR-DRIVE SHAFT INSTRUMENT WAS NOTED TO BE STRIPPED AND NOT WORKING CORRECTLY. ALSO, THE RATCHET T-HANDLE INSTRUMENT WOULD NOT SPIN, CAUSING INSTRUMENT TO NOT TIGHTEN DURING IMPLANT INSERTION. BACK UP INSTRUMENTS WERE AVAILABLE IN THE OPERATING ROOM. NO FRAGMENTS WERE GENERATED DURING THE REPORTED INSTRUMENT EVENTS. A FIVE (5) MINUTE SURGICAL DELAY WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES: UNKNOWN SCREWS (ITEM # UNKNOWN, LOT # UNKNOWN, QUANTITY 8), UNKNOWN OPAL SPACER (ITEM # UNKNOWN, LOT # UNKNOWN, QUANTITY 2), UNKNOWN RODS (IT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6515054 ↗