NA 02.231.290Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982062253), received between Jun 26, 2020 and Apr 11, 2023 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE MEDICAL RECORDS RECEIVED ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL FEMUR FRACTURE DUE TO RIGHT PERIPROSTHETIC DISTAL FEMUR FRACTURE. ON (B)(6) 2022 THE PATIENT HAD A REVISION DUE TO NONUNION RIGHT DISTAL FEMUR SHAFT FRACTURE ABOUT TOTAL KNEE ARTHROPLASTY (TKA). THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/90MM. THIS IS REPORT 10 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16718087 ↗
• InjuryApr 14, 2022Migration; Migration

  IT WAS REPORTED THAT DISTAL FEMUR OPEN REDUCTION INTERNAL FIXATION REVISION OCCURRED ON (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 2 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 14111085 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. THE SCREW LENGTH OF THE 4 VARIABLE ANGLE LOCKING SCREW AND 1 CANNULATED VARIABLE ANGLE LOCKING SCREW WERE TOO LONG AND WERE CAUSING PAIN. THE SCREWS WERE REPLACED WITH SHORTER SCREWS. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CURVED CONDYLAR PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10201361 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. THE SCREW LENGTH OF THE FOUR (4) VARIABLE ANGLE LOCKING SCREW AND ONE (1) CANNULATED VARIABLE ANGLE LOCKING SCREW WERE TOO LONG AND WERE CAUSING PAIN. THE SCREWS WERE REPLACED WITH SHORTER SCREWS. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CURVED CONDYLAR PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10201144 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. THE SCREW LENGTH OF THE FOUR (4) VARIABLE ANGLE LOCKING SCREW AND ONE (1) CANNULATED VARIABLE ANGLE LOCKING SCREW WERE TOO LONG AND WERE CAUSING PAIN. THE SCREWS WERE REPLACED WITH SHORTER SCREWS. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CURVED CONDYLAR PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10200941 ↗

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