NA 174168000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034018140), received between Nov 29, 2018 and Nov 29, 2018 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2018Break; Break

  IT WAS REPORTED THAT THE TITANIUM SCREW HEAD WAS BROKEN (DETACHED) DURING THE SPINE FUSION SURGERY ON (B)(6) 2018 WHEN THE SURGEON INSERTED THE 3RD SCREW INTO TITANIUM RING (P/N: 1741-73-000) TO FIX TITANIUM MESH (P/N: 1741-48-000). THE BROKEN SCREW COULD NOT BE REMOVED FROM TITANIUM RING (P/N: 1741-73-000) SO THAT THE SURGEON CUT THE TITANIUM MESH (P/N: 1741-48-000) TO MAINTAIN IN 30MM DIMENSION. THEN, IT WAS ALSO REPORTED THAT ANOTHER SCREW HEAD WAS BROKEN (DETACHED) WHEN THE SURGEON IMPLANTED THE ABOVE CUT TITANIUM MESH WITH 1ST BROKEN SCREW. THE SURGEON DECIDED TO IMPLANT THE REMAINED THE TITANIUM MESH INTO THE PATIENT¿S BODY WITH BROKEN SCREW. THERE WAS LESS THAN 30MIN. SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116447 ↗
• MalfunctionNov 29, 2018Break; Break

  IT WAS REPORTED THAT THE TITANIUM SCREW HEAD WAS BROKEN (DETACHED) DURING THE SPINE FUSION SURGERY ON (B)(6) 2018 WHEN THE SURGEON INSERTED THE 3RD SCREW INTO TITANIUM RING (P/N: 1741-73-000) TO FIX TITANIUM MESH (P/N: 1741-48-000). THE BROKEN SCREW COULD NOT BE REMOVED FROM TITANIUM RING (P/N: 1741-73-000) SO THAT THE SURGEON CUT THE TITANIUM MESH (P/N: 1741-48-000) TO MAINTAIN IN 30MM DIMENSION. THEN, IT WAS ALSO REPORTED THAT ANOTHER SCREW HEAD WAS BROKEN (DETACHED) WHEN THE SURGEON IMPLANTED THE ABOVE CUT TITANIUM MESH WITH 1ST BROKEN SCREW. THE SURGEON DECIDED TO IMPLANT THE REMAINED THE TITANIUM MESH INTO THE PATIENT¿S BODY WITH BROKEN SCREW. THERE WAS LESS THAN 30-MINS. SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116402 ↗