NA 212.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982152190), received between Oct 11, 2019 and Nov 10, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021. THE PATIENT UNDERWENT FOR A SURGERY. DURING A SURGERY, THERE WAS A REVISION FIXATION DUE TO FRACTURE DISTAL TO HARDWARE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 36. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12788445 ↗
• MalfunctionOct 11, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, A REVISION SURGERY WAS SCHEDULED DUE TO A POSSIBLE REFRACTURE AND OR NON-UNION. THE CONSTRUCT ORIGINALLY IMPLANTED WAS IMPLANTED OFF-LABEL. THE REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2019 AND WILL BE PERFORMED BY ANOTHER SURGEON. ORIGINAL IMPLANT DATE WAS ON (B)(6) 2019. IT IS UNKNOWN IF THE RE-SCHEDULED SURGERY HAS OCCURRED. DURING INVESTIGATION OF THE RETURNED DEVICES IT WAS NOTED THAT PORTIONS OF THE THREADS ON THE SHAFT OF THE SCREW WERE STRIPPED. CONCOMITANT DEVICES: CORTEX SCREW (PART 214.838, LOT 9202997, 9271477, L888929, QUANTITY 3); CORTEX SCREW (PART 214.840, LOT L663008, QUANTITY 1); LOCKING SCREW (PART 212.212, LOT 9201970, QUANTITY 1); SCREW (PART/LOT UNKNOWN, QUANTITY 1). THE LINKED EVENT IS CAPTURED IN (B)(4). THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181144 ↗