NA 04.112.623SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982279309), received between Oct 26, 2022 and May 21, 2025 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Migration; Migration

  SUBJECT ID: (B)(6). STUDY NO: NO INFORMATION PROVIDED. CLINICAL ADVERSE EVENT RECEIVED FOR (PAIN/DISCOMFORT/PROMINENCE) LOCAL PAIN NUMERIC RATING SCALE (NRS) =5. DEVICE RELATED: POSSIBLE. PROCEDURE RELATED: NO. DATE OF EVENT: 2024- OCT- 30. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 22063052 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR A MIDSHAFT CLAVICLE FRACTURE OF THE RIGHT SIDE. AFTER THE SURGERY, FOUR SCREWS ON THE PROXIMAL SIDE WERE FOUND TO BE BROKEN OFF AT THEIR NECKS ON X-RAY. THE IMPLANTS WERE REMOVED AND FIXATION USING A PLATE WAS DONE ON (B)(6) 2024. THE SURGEON CONFIRMED THAT THERE WERE NO PIECES LEFT IN THE PATIENT¿S BODY. THE SURGEON COMMENTED THAT THE SCREWS FELT LOOSE WHEN REMOVING THEM, AND SUSPECTS THAT THE EVENT MIGHT HAVE BEEN CAUSED BY A PATIENT FALL, DESPITE THE PATIENT STATING THAT HE DID NOT FALL. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS2/ RIGHT/ STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Fall

  MAUDE report 18630592 ↗
• MalfunctionApr 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A RIGHT CLAVICLE FRACTURE WITH THE VA-LCP PLATE IN QUESTION. THE FRACTURE SITE WAS MAINTAINED IN REDUCED POSITION BY INSERTING A LAG SCREW AND FURTHER FIXED WITH CS2 DIAPHYSEAL PLATE. THEN, THE LOCKING SCREW IN QUESTION WAS INSERTED, BUT METAL FRAGMENTS WERE GENERATED AT THAT TIME. BOTH THE SCREW AND PLATE WERE IMPLANTED IN THE PATIENT, AND ONLY THE METAL PIECES WERE COLLECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCP CLAVICLE PLATE SHAFT, CS2, RIGHT STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809244 ↗
• InjuryOct 26, 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: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY WITH THE PRODUCTS IN QUESTION FOR CLAVICLE TRUNK FRACTURE DUE TO A MOTORCYCLE ACCIDENT. AT THE END OF (B)(6), THE PATIENT HAD SEVERE PAIN WHILE DRIVING AND CONTINUED TO HAVE PAIN AFTERWARDS, SO HE WAS EXAMINED. IT WAS FOUND BY EXAMINATION THAT FOUR VA 2.7MM LOCKING SCREWS ON THE DISTAL SIDE AND ONE VA 2.7MM LOCKING SCREW ON THE PROXIMAL END, FOR A TOTAL OF FIVE SCREWS, WERE BROKEN. ALSO, THE FRACTURE AREA WAS PSEUDORADICULAR. ON (B)(6) 2022, SINCE THE BONE WAS NOT FUSED, THE SURGEON REMOVED ALL FOUR BROKEN SCREWS, PERFORMED AN ILIAC BONE GRAFT, AND FIXED WITH THE ANTERIOR CLAVICLE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE DOCTOR CONFIRMED BY X-RAY THAT THERE WERE NO REMAINING DAMAGED SCREWS IN THE BODY. REGARDING THE CAUSE OF THE BREAKAGE, THE SURGEON COMMENTED THAT THE LOCKING SCREW MAY HAVE BROKEN BECAUSE OF ITS NARROW DIAMETER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS2/ RIGHT/ STERILE. THIS IS REPORT 6 OF 6 FOR (B)(4).

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

  MAUDE report 15673090 ↗

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