NA 04.112.612SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982279217), received between Nov 18, 2022 and Jun 4, 2024 — classified as 3 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K201321, K203414); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR A FRACTURE OF THE LEFT CLAVICLE SHAFT. AFTER THE SURGERY, 2 OUT OF 4 SCREWS WHICH HAD BEEN INSERTED INTO PROXIMAL BROKE OFF. THE PROXIMAL PART OF THE PLATE BOUNCED UP, AND THE FRACTURE SITE BECAME POOR REDUCTION STATE. THE PATIENT REFUSED TO HAVE A REVISION SURGERY, SO THE PATIENT WAS UNDER OBSERVATION FOR ABOUT A YEAR. AS PSEUDARTHROSIS OCCURRED AND CT IMAGING DID NOT SHOW BONE UNION, ALL THE PLATE AND SCREWS WERE REMOVED, AND A REVISION SURGERY WAS PERFORMED WITH A COMPETITOR¿S CLAVICLE PLATE ON (B)(6) 2024. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED AS FOLLOWS: BECAUSE THE PLATE WAS SHORT AND BARELY FIXED WITH JUST 4 SCREWS EACH ACROSS THE FRACTURE, IT IS THOUGHT THAT STRESS WAS CONCENTRATED ON THE SCREWS, LEADING TO THE FRACTURE. HOWEVER, IF THE PLATE USED IN THE INITIAL SURGERY HAD BEEN A 3.5MM STANDARD, IT WOULD NOT HAVE LED TO THIS CASE OF BREAKAGE. THIS REPORT INVOLVES ONE (1) 2.7MM TI VA LCP CLAVICLE PLATE LATERAL/ CS2/ LEFT/ STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19458354 ↗
• MalfunctionApr 8, 2024Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR A CLAVICLE FRACTURE. AFTER THE SURGERY, IT WAS FOUND THAT THE LATERAL OF THE PLATE WAS BACKED OUT IN A WAY THAT IT WAS BOUNCING UP ALONG WITH THE SCREW. NO REVISION SURGERY IS PLANNED BECAUSE THE PATIENT IS NOT COMPLAINING OF PAIN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE VA-LCP CLAVIC PL 2.7 LAT CS2 LE TAN THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19060108 ↗
• InjuryJun 14, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL CLAVICLE FRACTURE WITH CLAVICLE PLATE AND SCREWS. THE SURGEON FIXED THE PLATE WITH SIX DISTAL AND FOUR PROXIMAL SCREWS. AND IT WAS REPORTED THAT THE SCREW OF THE DISTAL CLAVICLE PLATE WAS BROKEN AND WAS TO BE REMOVED AND REPLACED WITH A HOOK PLATE. THE SURGEON COMMENTED THAT IT WAS NOT CAUSED BY THE IMPLANTS BECAUSE THE PATIENT RODE A BICYCLE DESPITE HIS PROHIBITION AND FELL, STRIKING HIS SHOULDER. X-RAYS SHOWED THAT THE TWO MOST DISTAL ROW SCREWS WERE BROKEN OFF AND THE PLATE WAS DISLODGED UPWARD FROM THE DISTAL BONE FRAGMENTS. THE PROXIMAL SCREWS WERE UNCHANGED. THE CLAVICLE PLATE WILL BE REMOVED ON (B)(6) 2023, AND REVISION SURGERY WILL BE PERFORMED WITH ANOTHER CLAVICLE PLATE . THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS OR OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)VA-LCP CLAVIC PL 2.7 LAT CS2 LE TAN. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Fall

  MAUDE report 17128958 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SCREW BREAKAGE . THIS PC REPORTS THE PAIN. IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT HAD AN INJURY TO THE CLAVICLE, AND AFTER CONSERVATIVE TREATMENT, PSEUDOARTHROSIS DEVELOPED. ON (B)(6) 2022, THE PATIENT UNDERWENT THE CLAVICLE FRACTURE PSEUDOARTHROPLASTY WITH THE PRODUCTS IN QUESTION BECAUSE SHE WAS CONCERNED ABOUT THE PROTRUSION OF HER COLLARBONE. DURING AN OUTPATIENT VISIT ON (B)(6) 2022, THE PATIENT WAS OBSERVED TO HAVE 5 DISTAL SCREW FRACTURES. SINCE THERE WERE NO COMPLAINTS OF PAIN AT THIS POINT, THE PATIENT WAS DECIDED TO BE FOLLOWED UP. IN LATE (B)(6) 2022, THE PATIENT COMPLAINS OF PAIN AND THE IMPLANTS WERE DETERMINED TO BE REMOVED. ON (B)(6) 2022, THE IMPLANTS WERE REMOVED. IT WAS OBSERVED THAT FIVE DISTAL SCREWS BROKEN OFF AT THE BASE OF THE HEAD. THE SCREW SHAFT PORTION APPEARED TO PROTRUDE OUTSIDE THE BONE ON THE X-RAY, BUT AFTER THE PLATE WAS REMOVED, THE SCREW SHAFT PORTION COULD NOT BE SEEN DUE TO SCARRING. THE SURGEON USED A HALO REAMER TO CUT THE BONE IN THE FRONT AND THEN USED RADIO PLIERS AND SCREW GRASPING FORCEPS TO SAFELY REMOVE THE IMPLANTS

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15824838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201321, K203414. One submission often covers many models, so check the product and lot details in each record.

• Z-1241-2024 · Jan 24, 2024 · Open, Classified
  VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S