NA 03.611.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034713823), received between Apr 20, 2017 and Apr 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT PATIENT WAS INITIALLY IMPLANTED WITH A T10-PELVIS CONSTRUCT USING DEPUY SPINE IMPLANTS. THE DATE OF THE INITIAL SURGERY IS NOT KNOWN. ON UNKNOWN DATE IT WAS DISCOVERED PATIENT HAD A BROKEN ROD AND WAS RETURNED TO SURGERY ON (B)(6) 2017. DURING THE REVISION, THE RODS BELOW THE L2 SCREWS WERE REMOVED, AS WERE THE L3,L4,L5,S1 AND SACRAL-ALAR-ILIAC (SAI)SCREWS BILATERALLY. ALL OF THE SCREWS CAME OUT WITH EASE. DURING INSERTION OF THE NEW SAI SCREWS, ONE OF THE SCREWS GOT STUCK ABOUT THREE QUARTERS OF THE WAY INSERTED. THE SURGEON THEN ATTEMPTED TO BACK OUT THE SCREW ENTIRELY. HE TRIED TO USE AN 8.0 MM SCREW REMOVER BUT WAS UNSUCCESSFUL. THE SURGEON THEN DECIDED TO CUT OFF THE POLYAXIAL HEAD FROM THE SCREW AND USED A PAIR OF TREPHINES AND SYNTHES FEMALE EASY-OUTS. AFTER ABOUT 10 MINUTES AND A LOT OF FORCE, THE SURGEON WAS FINALLY ABLE TO BACK OUT THE SCREW USING THE 9MM SCREW REMOVER. HOWEVER, THE SCREW BECAME STUCK INSIDE THE SCREW REMOVER. WITH THE BROKEN SCREW AND ALL FRAGMENTS SUCCESSFULLY REMOVED, THE SURGEON WAS ABLE TO IMPLANT THE SAME TYPE OF SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. BROKEN ROD AND REVISION SURGERY CAPTURED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6508475 ↗