NA 04.112.615SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982279255), received between Jul 18, 2022 and Sep 3, 2024 — classified as 3 injuries.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF WITH THE CLAVICLE PLATE FOR RIGHT CLAVICLE PSEUDOARTHROSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, THE SECONDARY FRACTURE OCCURRED NEAR PROXIMAL PLATE DUE TO FALL. ON (B)(6) 2024, A REVISION SURGERY WILL BE PERFORMED. THIS REPORT IS FOR ONE 2.7MM TI VA LCP CLAVICLE PLATE LATERAL/CS3/RIGHT/STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 20126327 ↗
• InjuryJan 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION FOR A CLAVICLE FRACTURE WITH THE PRODUCT IN QUESTION. VA-CLP WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PROXIMAL SCREW BROKE OFF. REOPERATION WAS SCHEDULED FOR ON (B)(6) 2022. THE SURGEON COMMENTED ¿I SHOULD HAVE CHOSEN ONE SIZE LONGER FOR THE PLATE. LOCKING WAS PLACED NEAR THE FRACTURE SITE, AND ONE FIXATION WAS NOT COUNTED. PATIENT WAS WORKING TOO HARD IN REHABILITATION AND MOVING TOO OFTEN¿. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE2.7MM TI VA LCP CLAVICLE PLATE LATERAL/ CS3/ RIGHT/ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16111762 ↗
• InjuryJul 18, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE DISTAL CLAVICULAR OF RIGHT FRACTURE WITH THE PLATE AND SCREWS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2022, SEVERAL MALFUNCTIONS WERE OBSERVED IN OUTPATIENT FOLLOW-UP EXAMINATION AS FOLLOWS. THE RIGHT CLAVICLE HAS OBVIOUS TENTING. IT WAS CONFIRMED BY COMPUTED RADIOGRAPHY (CR) IMAGE THAT TWO SCREWS INSERTED INTO THE DISTAL BONE FRAGMENT WERE BROKEN. THOSE LOT OR SIZE COULD NOT BE IDENTIFIED. TWO OTHER SCREWS INSERTED INTO THE DISTAL BONE HAS BACKED OUT. THE PLATE HAS BEEN DISLODGED. THE PATIENT HAS NO SUBJECTIVE SYMPTOM. A REVISION SURGERY WILL OCCUR BUT IT IS NOT KNOWN IF IT HAS BEEN COMPLETED. THIS IS REPORT 1 OF 9 FOR (B)(4). THIS REPORT IS FOR A CLAVICLE PLATE.

  Patient problems: Failure of Implant

  MAUDE report 15041421 ↗

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