VA-LCP 02.112.047Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982033031), received between Dec 16, 2020 and Sep 17, 2021 — classified as 5 injuries.

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.

• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SHAFT FRACTURE FIXATION UTILIZING VA-LCP ANTERIOR PLATE. POSTOPERATIVELY PATIENT HAD A DIFFICULTY WITH OVERHEAD ACTIVITIES/LIFTING AND THE DECREASED RANGE OF MOTION (ROM) ON THE OPERATIVE SIDE. UNION WAS ACHIEVED AFTER 12 WEEKS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Loss of Range of Motion

  MAUDE report 12492311 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING VA-LCP ANTERIOR PLATE. THE PATIENT SUFFERING OF IMPINGEMENT, RECURRENT PAIN/SORENESS POST-OPERATIVELY. UNION WAS ACHIEVED AFTER 10 WEEKS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: CORTEX (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 8). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM. THIS REPORT IS 1 OF 9 FOR (B)(4).

  Patient problems: Nerve Damage; Pain

  MAUDE report 12461514 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING VA-LCP ANTERIOR PLATE. PAIN MANAGEMENT 2/2 SURGERY WAS OBSERVED POST-OPERATIVELY AND UNION WAS ACHIEVED AFTER 12 WEEKS. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 10). THIS REPORT IS FOR ONE (1) 2.7/3.5 VA LAT ANT CLAV PL/10 HOLE/101. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12392525 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A LATERAL FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. THERE WAS A UNION OF FRACTURE AFTER 6 WEEKS DURATION AND NO POST-OPERATIVE COMPLICATIONS REPORTED. PATIENT WAS RE-OPERATED DUE TO HARDWARE REMOVAL AND COULD FEEL IMPLANT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: CORTEX (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12384955 ↗
• InjuryDec 16, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN VA-LCP ANTERIOR CLAVICLE PLATE. DURING THE REVISION PROCEDURE, THE REPORTED PLATE WAS REMOVED ALONG WITH THE THREE (3) UNKNOWN 3.5MM CORTEX SCREWS AND THREE (3) UNKNOWN 2.7MM CORTEX SCREWS. THE PATIENT WAS THEN REVISED TO A NEW VA-LCP ANTERIOR CLAVICLE PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN 3.5MM CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3) . 2.7MM CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021426 ↗