VA-LCP 02.117.704Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982037220), received between Aug 20, 2018 and Dec 8, 2020 — classified as 4 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K120070); 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.

• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THREE ELBOW PLATES AND SCREWS WERE REMOVED. THE PATIENT WANTED THE HARDWARE REMOVED. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10968780 ↗
• InjuryNov 18, 2020Break; Break

  UPDATED CONCOMITANT DEVICE REPORTED: SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 5), VA LOCKING SCREW (PART 02.211.050, LOT UNKNOWN, QUANTITY 1), VA LOCKING SCREW (PART 02.211.018, LOT UNKNOWN, QUANTITY 1), VA LOCKING SCREW (PART 02.211.020, LOT UNKNOWN, QUANTITY 1), VA LOCKING SCREW (PART 02.211.028, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10862059 ↗
• InjuryDec 11, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE IN 2018. A BROKEN DISTAL HUMERUS PLATE, AN UNKNOWN 3.5 CORTEX SCREW, TWO (2) 3.5 LOCKING SCREWS, AND FOUR (4) VARIABLE ANGLE LOCKING SCREWS WERE REMOVED SUCCESSFULLY. THE ORIGINAL SURGERY DATE WAS ON (B)(6) 2018. SURGICAL OUTCOME AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN 3.5MM LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). UNKNOWN 2.7MM VARIABLE-ANGLE (VA) LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4). THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8150982 ↗
• InjuryAug 20, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION AND HARDWARE REMOVAL OF THE VARIABLE ANGLE LOCKING COMPRESSION (VA-LCP) EXTENDED MEDIAL PLATE AND UNKNOWN SCREWS DUE TO THE PLATE BEING BROKEN AT THE FIRST 3.5 SCREW HOLE AND THE FRACTURE NOT BEING HEALED. DURING THE REVISION, A BRAND-NEW PLATE WITH SAME ITEM NUMBER WAS IMPLANTED. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN PLATE, AND THEY WERE EASILY REMOVED. THE PATIENT ORIGINALLY HAD SURGERY ON (B)(6) 2018 DUE TO DISTAL HUMERUS FRACTURE AND WAS TREATED WITH THE VA ELBOW SET WHERE AN VA EXTENDED MEDIAL DISTAL HUMERUS PATE WAS IMPLANTED ALONG WITH A VA POSTERIOR LATERAL DISTAL HUMERUS PLATE AND A VA OLECRANON PLATE. THE VA EXTENDED MEDIAL PLATE WAS DISCOVERED BROKEN VIA X-RAY ON AN OFFICE VISIT FOLLOW-UP ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP EXTENDED MEDIAL DISTAL HUMERUS PLATE 4-HOLE/LEFT/111MM-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7796645 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes