NA 02.206.226Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982051042), received between Jan 8, 2018 and Jul 15, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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

• InjuryJul 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIAL PLATE 10 HOLES RIGHT DUE TO NONUNION. THERE WERE SIX (6) 2.7 MM VARIABLE ANGLE LOCKING SCREWS REMOVED, OUT OF SIX (6) SCREWS TWO (2) WERE BROKEN. ALSO HAD FOUR (4) 3.5 CORTEX SCREWS THAT WERE REMOVED AS WELL, THREE (3) OUT OF 4 SCREWS WERE BROKEN. THE 2.7 MM LOCKING COMPRESSION PLATE 7 HOLES PLATE WAS REMOVED, WITH THAT PLATE THERE WERE (6) 2.7 MM CORTEX SCREWS ONE (1) WAS BROKEN.  THE SURGEON REPLACE THE TIBIAL WITH ANOTHER VARIABLE ANGLE (VA) ANTEROLATERAL DISTAL TIBIA PLATE. IT WAS A 14-HOLE RIGHT. ENDED UP WITH A (4) CORTEX SCREWS IN THE SHAFT AND 5 (VA) LOCKING SCREW DISTALLY. THERE WAS ONE FRAGMENT THAT IS NON-RETRIEVABLE IT WAS THE SCREWS WERE INCASED IN BONE, IT WAS NOT REMOVED TO AVOID EXTENSIVE DISSECTION. IT WAS LEFT IN THE PATIENT AND NO PLAN TO REMOVE. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2018. OTHER THAN THE TIMES IT TAKES TO REMOVE THE HARDWARE THERE WERE NO OTHER SURGICAL DELAYS. ALL OTHER HARDWARE WAS REMOVED COMPLETELY AND SUCCESSFULLY. PROCEDURE OUTCOME WAS GOOD. PATIENT WAS IN STABLE CONDITION AND TO

  Patient problems: No Code Available

  MAUDE report 8789723 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 1 OF 4 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 20 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8641652 ↗
• InjuryMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 8 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 8640652 ↗
• InjuryJan 8, 2018Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 FOR REMOVAL OF 2.7/3.5MM VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) MEDIAL DISTAL TIBIA PLATE/8 HOLES/LEFT IMPLANTED ON (B)(6) 2017. THE HARDWARE REMOVAL WAS DUE SIX BROKEN SCREWS AND NON-UNION. THE HEADS OF THE TWO 3.5MM CORTEX SCREW 26MM, ONE 3.5MM CORTEX SCREW 28MM AND THREE UNKNOWN LOCKING SCREWS WERE REMOVED. THE SHAFT OF ALL THESE SCREWS WERE RETAINED IN THE PATIENT AND WERE NOT REMOVED. NOTHING WAS IMPLANTED DURING REVISION SURGERY AS THE SURGEON JUST WANTED TO RULE OUT THE INFECTION BY REMOVING THE BROKEN SCREWS. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT DEVICES REPORTED: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/8 HOLES/LEFT (PART # 02.118.007, LOT # UNKNOWN, QTY # 1). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW 26MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7173538 ↗
• InjuryJan 8, 2018Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 FOR REMOVAL OF 2.7/3.5MM VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) MEDIAL DISTAL TIBIA PLATE/8 HOLES/LEFT IMPLANTED ON (B)(6) 2017. THE HARDWARE REMOVAL WAS DUE SIX BROKEN SCREWS AND NON-UNION. THE HEADS OF THE TWO 3.5MM CORTEX SCREW 26MM, ONE 3.5MM CORTEX SCREW 28MM AND THREE UNKNOWN LOCKING SCREWS WERE REMOVED. THE SHAFT OF ALL THESE SCREWS WERE RETAINED IN THE PATIENT AND WERE NOT REMOVED. NOTHING WAS IMPLANTED DURING REVISION SURGERY AS THE SURGEON JUST WANTED TO RULE OUT THE INFECTION BY REMOVING THE BROKEN SCREWS. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT DEVICES REPORTED: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/8 HOLES/LEFT (PART # 02.118.007, LOT # UNKNOWN, QTY # 1). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW 26MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7173537 ↗