NA 02.231.255Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982062185), received between Mar 9, 2018 and Apr 14, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083025, K110354); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2022Migration; Migration

  IT WAS REPORTED THAT DISTAL FEMUR OPEN REDUCTION INTERNAL FIXATION REVISION OCCURRED (B)(6) 2022 DUE TO MULTIPLE 5.0MM VA LOCKING SCREWS BACKING OUT OF PLATE. IT IS UNKNOWN WHEN THE ORIGINAL SURGERY OCCURRED. DURING THE REVISION THE SURGEON ATTEMPTED TO RE-TIGHTEN THE SAME SCREW BACK INTO THE PLATE WITH A SCREWDRIVER AND APPROPRIATE 6NM TOQUE LIMITING T HANDLE. THE RE-TIGHTENING OF THE SCREWS DID NOT WORK AS THE SCREW HEADS WERE NOT LOCKING INTO THE PLATE. UPON REMOVAL AND INSPECTION OF THE ORIGINAL 12H VARIABLE ANGLE CURVED CONDYLAR PLATE, IT WAS NOTED BY SURGEON THAT THE SCREW HOLES OF THE PLATE AND THE LOCKING THREADS ON THE 5.0MM VARIABLE ANGLE LOCKING SCREWS WERE COMPROMISED. HE HAD TO PLACE A NEW PLATE AND SCREWS IN THE PATIENT AS A CORRECTION FOR THE ORIGINAL SURGERY. NO SURGERY DELAYED AND THE PROCEDURE SUCCESSFULLY COMPLETED. THIS IS REPORT 5 OF 6 FOR (B)(4). THIS REPORT IS FOR A 5.0 VA LOCKING SCREW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14111842 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES; THIS REPORT IS AGAINST USER FACILITY REPORT MW5074624. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE MAUDE EVENT REPORT IS ATTACHED. IT WAS REPORTED THAT ON AN UNKNOWN DATE APPROXIMATELY THREE YEARS AGO, PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN TOTAL KNEE ARTHROPLASTY (TKA) CONSTRUCT (MANUFACTURER UNKNOWN). ON (B)(6) 2016, PATIENT UNDERWENT IMPLANT PROCEDURE TO TREAT LOSS STRESS FEMURE FRACTURE. PATIENT WAS IMPLANTED WITH ONE 4.5 MM (1) VARIABLE ANGLE (VA) CURVED CONDYLAR PLATE, EIGHT (8) 5.0 MM VA LOCKING SCREWS, ONE (1) 5.0 MM CANNULATED VA LOCKING SCREW, ONE (1) 4.5 MM CORTEX SCREW. SUBSEQUENTLY, ON AN UNKNOWN DATE, JUST FIFTY-ONE (51) DAYS AFTER THE PATIENT BEING RELEASED TO A FULL WEIGHT BEARING STATUS, THE PLATE BROKE AND THE PATIENT DEVELOPED A NONUNION AND THE BONE HAD RE FRACTURED. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY. THE SURGEON WENT INTO SURGERY WITH THE PLAN TO NOT REMOVE THE IMPLANTS, BUT SUBSEQUENTLY, ENDED UP REMOVING ALL IMPLANTS. THE SURGEON CUT OUT THE TISSUE SURROUNDING THE PLATE AND THE PLATE WAS STILL STUCK.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7327521 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083025, K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra