NA 02.127.142Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982043252), received between Jan 16, 2018 and Apr 21, 2022 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT A 3.5 VA LOCKING SCREW INTO A VA LOCKING HOLE, THE SCREW WOULD NOT LOCK INTO THE PLATE. A 3.5 CORTEX SCREW WAS PLACED IN THE HOLE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ADDITIONALLY, IT WAS REPORTED THAT A PERIARTICULAR REDUCTION FORCEPS WAS DIFFICULT TO OPEN. HOWEVER, IT OPENED FREELY ONCE IT WAS WET WITH IRRIGATION. IT WAS BELIEVED TO HAVE BIOBURDEN. THE FORCEPS REMAINED STIFF POSTOPERATIVELY AFTER WASHING. THIS REPORT IS FOR THE LOCKING SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171775 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A 1 PLATE, 4 CORTEX SCREW. 4 VARIABLE ANGLE LOCKING COMPRESSION SCREW AND 1 METAPHYSEAL SCREW ON (B)(6) 2017 DUE TO RIGHT TIBIAL INFECTION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE DEVICES WERE REMOVED INTACT AND AN ANTIBIOTIC NAIL WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THE PATIENT MAY BE SCHEDULED FOR ADDITIONAL SURGERIES AS PART OF A STAGED RE-IMPLANTATION. THIS COMPLAINT IS FOR TEN (10) DEVICES. (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7194364 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A 1 PLATE, 4 CORTEX SCREW. FOUR (4) VARIABLE ANGLE LOCKING COMPRESSION SCREW AND 1 METAPHYSEAL SCREW ON (B)(6) 2017 DUE TO RIGHT TIBIAL INFECTION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE DEVICES WERE REMOVED INTACT AND AN ANTIBIOTIC NAIL WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THE PATIENT MAY BE SCHEDULED FOR ADDITIONAL SURGERIES AS PART OF A STAGED RE-IMPLANTATION. THIS COMPLAINT IS FOR TEN (10) DEVICES. THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7194286 ↗