NA 02.231.285Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982062246), received between Mar 9, 2018 and Apr 14, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Adverse 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 HAD A FALL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE REQUIRING OPEN REDUCTION INTERNAL FIXATION (ORIF). THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. IMPLANTS DID NOT APPEAR TO BE REMOVED. ON (B)(6) 2021, X-RAY TAKEN SHOWED PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. ON (B)(6) 2021, INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. ON (B)(6) 2021, SURGEON STATED, THAT THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN. ON (B)(6) 2021, X-RAY RESULTS STATED, THAT THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. SURGEON STATES, LEFT KNEE IS UNSTABLE LIKELY SECONDARY TO MALUNION OF THE FEMUR FRACTURE WITH RESULTANT SHORTENING. ON (B)(6) 2021, PATIENT SUSTAINED TWO FALLS RESULTING IN A PELVIC AND THEN A RIGHT HUMERAL FRACTURE. MEDICAL RECORDS DO NOT INCLUDE THE PRIMARY OPERATIVE NOTES, NOR THE

  Patient problems: Bone Fracture(s); Malunion of Bone; Pain

  MAUDE report 16747877 ↗
• 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 FEBRUARY 25, 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/85MM. THIS IS REPORT 9 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16718066 ↗
• 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 4 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 14111769 ↗
• 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 4 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10201214 ↗
• 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 1 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10200851 ↗
• InjuryOct 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A LOSS OF DISTAL FIXATION. THE PATIENT INITIALLY HAD AN OPEN REDUCTION INTERNAL FIXATION LEFT FEMUR SURGERY ON (B)(6) 2018. A VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE WAS IMPLANTED WITH FOUR (4) LOCKING SCREWS DISTALLY AND FOUR (4) CORTICAL SCREWS PROXIMALLY. IT WAS REPORTED THAT THE DISTAL LOCKING SCREWS BACKED OUT. THE SURGEON REMOVED THE VA LCP PLATE AND CONVERTED TO AN EXTERNAL FIXATOR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT SPECIFIED. CONCOMITANT DEVICE REPORTED: 4.5MM TI CORTEX SELF-TAPPING 32MM (PART NUMBER 414.832, LOT UNKNOWN, QUANTITY 1); 4.5MM TI CORTEX SELF-TAPPING 38MM (PART NUMBER 414.838, LOT UNKNOWN, QUANTITY 2); 4.5MM TI CORTEX SELF-TAPPING 85MM (PART NUMBER 414.885, LOT UNKNOWN, QUANTITY 1). 4.5MM TI CORTEX SCREW 85MM (PART NUMBER 414.085, LOT UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/85MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7938431 ↗
• 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. 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 FEMUR 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. SUBSEQUENTLY, THE SURGEON COULD REMOVE ALL IMPL

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7327528 ↗

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