NA 412.213Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982210975), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionNov 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF FEMORAL NECK SYSTEM. IT WAS NOTED THAT A 5.0 LOCKING SCREW COLD WELDED TO THE PLATE. THE SURGEON WAS UNABLE TO REMOVE THE HARDWARE THE HARDWARE WAS LEFT, IRRIGATED AND CLOSED IN. THERE WAS A TWENTY (20) MINUTE SURGICAL DELAY NOTED. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT INVOLVES ONE (1)5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 38MM. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787037 ↗