NA 02.130.253Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982044815), received between Aug 5, 2020 and Aug 5, 2020 — 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.

• MalfunctionAug 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JULY 14, 2020 AFTER THE INSERTION OF THE VARIABLE ANGLE (VA) LOCKING T-PLATE AND UNKNOWN LOCKING SCREW, THE SURGEON DECIDED TO CHANGE OUT THE SCREW FOR A DIFFERENT LENGTH. DURING THE RE-INSERTION OF A NEW UNKNOWN VA LOCKING SCREW, THE SCREW HEAD WOULD NOT LOCK INTO THE PLATE. THE PLATE WAS REMOVED AND A NEW PLATE WAS INSERTED. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.5MM VAL Y-PLATE 3 HOLES HD-7 HOLES SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10367875 ↗