NA 02.231.270Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982062215), received between Oct 5, 2018 and Apr 14, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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 4 most recent of 4 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 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 3 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 14111597 ↗
• MalfunctionDec 30, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE PLATING A DISTAL FEMUR THE VARIABLE ANGLE LOCKING SCREW ON THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE CROSS THREADED AND DID NOT LOCK INTO THE PLATE PROPERLY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/70MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122453 ↗
• 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/65MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7938447 ↗
• 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/70MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7938436 ↗

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