ABC FJ932TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653445028), received between Nov 8, 2022 and Nov 22, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATE: PATIENT HARM UPDATED TO NONE FROM UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849967 ↗
• InjuryNov 11, 2022Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FJ932T - ABC SELF-LOCKING CERVICAL SCREW 4.0X14MM. ACCORDING TO THE COMPLAINANT, THE ABC SCREW INNER LOCKING RING DID NOT RAISE INTO LOCKING POSITION WHEN SCREW DRIVER WAS DISENGAGED. SURGEON THEN ATTEMPTED TO USE THE LOCKING ASSISTANCE TOOL. THE WORKING THREADS BROKE OFF INSIDE THE LOCKING RING AND THE INNER SILVER LOCKING RING HEX HEAD BECAME STRIPPED. VARIOUS UNIVERSAL REMOVAL INSTRUMENTS WERE ALSO USED IN THE ATTEMPT. FINALLY, FIVE (5) SUCCESSFULLY IMPLANTED SCREWS HAD TO BE REMOVED; THE STRIPPED SCREW WAS REMOVED WITH LOCKING PLIERS, AND PLATE AND SCREW INSERTIONS WERE INITIATED AGAIN. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (9610612-2022-00324) FJ911R. (B)(4) FJ932T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781876 ↗
• InjuryNov 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO AESCULAP INC. THAT A ABC SELF-LOCKING CERVICAL SCREW 4.0X14MM (ITEM # FJ932T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SILVER LOCKING RING DID NOT RAISE TO LOCK THE SCREW IN PLACE WHEN THE SCREW DRIVER WAS DISENGAGED. IT WAS REPORTED THAT THE THREADS OF A LOCKING ASSISTANCE TOOL HAD BROKEN OFF INSIDE THE LOCKING RING, CAUSING THE SCREW TO BECOME STRIPPED. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AS A RESULT OF THIS EVENT ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. THE SURGEON HAD TO REMOVE FIVE SUCCESSFULLY IMPLANTED SCREWS AND REMOVED THE STRIPPED SCREW WITH LOCKING PLIERS. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE CC 400573256. THE ASSOCIATED MEDWATCH REPORTS # 2916714-2022-00109 (400573257).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751771 ↗