NA 04.112.621SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982279293), received between Jan 9, 2023 and Jun 4, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A FRACTURE OF THE DISTAL END OF THE CLAVICLE. ON AN UNKNOWN DATE AFTER THE SURGERY, THE SCREW BACKED OUT. IT WAS ALSO CONFIRMED THAT ONLY THREE SCREWS HAD BEEN INSERTED INTO THE PERIPHERAL BONE FRAGMENT ALTHOUGH FOUR SCREWS SHOULD HAVE BEEN INSERTED. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED, AND IT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT IS BELIEVED THAT THE IMPLANTS WERE OVERLOADED BECAUSE OF THE INSUFFICIENT NUMBER OF SCREWS AND THE FARM WORK THE PATIENT PERFORMED AFTER SURGERY. THIS REPORT IS FOR A 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ RIGHT/ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19462901 ↗
• InjuryJan 9, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR CLAVICULAR DIAPHYSIS WITH THE PRODUCTS IN QUESTION. TWO MONTHS LATER ON (B)(4) 2022, IT BACKED OUT. THE DOCTOR HAS CONFIRMED BY X-RAY THAT THERE ARE NO BROKEN PIECES OR OTHER RESIDUALS IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ RIGHT/ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16121073 ↗

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