NA 02.231.660Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982062871), received between Mar 9, 2018 and Jan 13, 2021 — classified as 5 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (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.

• InjuryJan 13, 2021Adverse 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 REMOVAL AND REVISION OF HARDWARE DUE TO FALL. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 5.0MM CANNULATED VA LOCKING SCREW/60MM. THIS REPORT IS 6 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165119 ↗
• InjuryJan 13, 2021Adverse 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 REMOVAL AND REVISION OF HARDWARE DUE TO FALL. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 5.0MM CANNULATED VA LOCKING SCREW/60MM. THIS REPORT IS 10 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165104 ↗
• InjuryJul 23, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT THE REMOVAL OF OSTEOSYNTHESIS MATERIAL AND A CONDYLAR SUPPORT PLATE THAT HAD FAILED. THE DISTAL LOCKING SCREWS OF THE PLATE WERE LOOSE AND ONE WAS ALREADY EXPOSED OUTSIDE OF THE SKIN. AN ADDITIONAL REDUCTION WAS PERFORMED BUT THE SCREWS DID NOT BLOCK THE PLATE AND IT WAS DECIDED TO REMOVE ALL THE MATERIAL AND PUT A SPLINT IN ONE OF THE WOUNDS THAT WAS FOUND TO BE INFECTED. THE FIRST INTERVENTION WAS PERFORMED BECAUSE THE DISTAL SCREWS OF THE PLATE CAME OFF. THE SECOND OPERATION WAS PERFORMED TO EXTRACT A SCREW THAT WAS EXPOSED THROUGH THE SKIN AND THE THIRD INTERVENTION WAS WHEN ALL OF THE MATERIAL WAS REMOVED. THE FIRST TWO INTERVENTIONS WERE PERFORMED TO REMOVE THE IMPLANT AND TRY TO CORRECT THE NEW FRACTURE, IN THE LAST SURGERY IT WAS SHOWN THAT THERE WAS AN INFECTION. THIS REPORT IS FOR ONE (1)5.0MM CANNULATED VA LOCKING SCREW/60MM. THIS IS REPORT 5 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10312176 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PARTIAL REVISION OF TOTAL KNEE AND KNEE MANIPULATION, AND WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, FOUR (4) 4.5MM CORTEX SCREWS, THREE (3) CANNULATED VA LOCKING SCREWS, AND TWO (2) 5.0MM CANNULATED VA LOCKING SCREWS ON UNKNOWN DATE IN 2016. ON UNKNOWN DATE PATIENT REPORTED PAIN AND STIFFNESS ASSOCIATED WITH THE IMPLANTS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AS THE FRACTURE HAD HEALED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW 60MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7328505 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PARTIAL REVISION OF TOTAL KNEE AND KNEE MANIPULATION, AND WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, FOUR (4) 4.5MM CORTEX SCREWS, THREE (3) CANNULATED VA LOCKING SCREWS, AND TWO (2) 5.0MM CANNULATED VA LOCKING SCREWS ON UNKNOWN DATE IN 2016. ON UNKNOWN DATE PATIENT REPORTED PAIN AND STIFFNESS ASSOCIATED WITH THE IMPLANTS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AS THE FRACTURE HAD HEALED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW 60MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7328462 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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