8.0 X 165mm Cann Screw Fastener Full Thd 380-5165-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810074306720), received between May 22, 2025 and May 22, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMay 22, 2025Break; Break

  DR. (B)(6) PERFORMED A REVISION SURGERY AT (B)(6) HOSPITAL TO ADDRESS A BROKEN 8.0MM FULLY THREADED PELVIC SCREW MANUFACTURED BY A COMPANY OTHER THAN OSTEOCENTRIC. THE SURGICAL TEAM BEGAN BY REMOVING THE DAMAGED SCREW. THEY ATTEMPTED TO PLACE AN OSTEOCENTRIC 8.0 X 165MM CAN SCREW FASTENER FULL THD, USING THE SAME PATH. HOWEVER, THEY WERE UNABLE TO FULLY SEAT THE FASTENER. THE FASTENER BECAME BENT, AND THE K-WIRE SNAPPED DURING REMOVAL. THE SYSTEM INCLUDES A TAP FOR USE IN DENSE BONE, HOWEVER IT WAS NOT USED IN THIS INSTANCE. THE SECOND ATTEMPT WITH ANOTHER OSTEOCENTRIC 8.0 X 165MM CANN SCREW FASTENER FULL THD THEY TRIED PLACING THE FASTENER, AND THIS TIME DRILLED AND TAPPED THE BONE TO REDUCE RESISTANCE. DESPITE THAT, THERE WAS STILL ENOUGH RESISTANCE NEAR THE END THAT THE FASTENER HEAD SNAPPED OFF WHEN ATTEMPTING TO SEAT IT AT THE ILIAC CREST. AFTER REMOVING THE BROKEN FASTENER, THE SURGEON RE-DRILLED AND TAPPED AGAIN, AND WAS THEN ABLE TO SUCCESSFULLY PLACE AN OSTEOCENTRIC 170MM, 8.0MM CANNULATED FASTENER. THERE WAS NO HARM TO THE PATIENT. THE BENT AND BROKEN FASTENER AND K-WIRE WERE FULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073586 ↗