NA 04.112.620SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982279262), received between Sep 14, 2022 and Oct 21, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT A REVISION SURGERY WAS NEEDED DUE TO PSEUDARTHROSIS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23349487 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT A REVISION SURGERY WAS NEEDED DUE TO PSEUDARTHROSIS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23349471 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR MIDSHAFT CLAVICLE FRACTURE WITH THE VACP CS1. ON (B)(6) 2025, THE SALES REP GOT AN INFORMATION THAT THE SCREWS BROKE AT THE REMOVAL SURGERY. WHEN THE SURGEON TURNED THE SCREWDRIVER TO REMOVE THE SCREWS, IT BROKE AT THE SCREW HEAD. USING PLIERS ETC., THEY WERE ALL REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22345854 ↗
• InjuryFeb 6, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A SURGERY WITH THE PLATE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, THE SALES REP WAS INFORMED THAT THE PLATE DISLOCATED. WHEN THE SALES REPRESENTATIVE WENT TO THE HOSPITAL TO CONFIRM THE X-RAY, IT WAS CONFIRMED THAT THE SCREW REMAINED IN THE PLATE AND THE DISTAL BONY FRAGMENT, WHICH WAS LUMPED WITH THE SHOULDER JOINT, WAS DISPLACED CAUDALLY BY THE WEIGHT OF THE ARM. NO SCREW FRACTURE DAMAGE WAS SEEN. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2025, TO REMOVE THE PLATE AND REPLACE WITH OTHER COMPANY¿S IMPLANTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21323482 ↗
• MalfunctionNov 6, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS STABLE AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622435 ↗
• MalfunctionJun 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MAY 15, 2024, THE PATIENT UNDERWENT THE SURGERY FOR CLAVICLE FRACTURE WITH THE VA CLAVICLE PLATE AND THE VA 2.7 LOCKING SCREW IN QUESTION. DURING SURGERY, THE SURGEON WAS CONCERNED ABOUT PLATE FLOATATION, SO HE INSERTED A VA 2.7 LOCKING SCREW WHILE HOLDING IT DOWN AND OBSERVED THE SCREW BREAKAGE UNDER THE SCREW HEAD. NOTHING REMAINS IN THE BODY HAVE BEEN REPORTED. THE DETAILS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19515595 ↗
• InjuryDec 1, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY ON (B)(6) 2022 FOR A CLAVICLE TRUNK FRACTURE WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON (B)(6) 2022, THE AGENCY CONTACTED AND VISITED THE SURGEON AND FOUND THAT THE PROXIMAL FIXATION HAD FAILED. 3DCT AND X-RAYS CONFIRMED THAT TWO SCREWS (ONE CORTICAL AND ONE LOCKING) IN THE PROXIMAL BONE FRAGMENT HAD BOUNCED UPWARD WITH THE PLATE AND WERE OUT OF THE BONE, WHILE THE REMAINING TWO LOCKING SCREWS REMAINED IN THE BONE WITH THE SCREW HEADS PENETRATING THE SCREW. THE POSITION OF THE IMPLANT APPEARED TO THE SURGEON TO BE GENERALLY FINE. THE IMPLANT HAD FAILED WHEN THE PATIENT SLEPT WITH THE AFFECTED SIDE DOWN AND WOKE UP IN THE MORNING. EXTRACTION WOULD BE PERFORMED ON (B)(6) 2022 AND THE FRACTURE WOULD BE REFIXED WITH A COMPETITOR PLATE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15893344 ↗
• MalfunctionOct 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION OF THE CLAVICLE ON (B)(6) 2022. WHILE THE SURGEON WAS FIXING THE MEDIAL FRAGMENT WITH THE CS1 PLATE, THE SURGEON DRILLED, MEASURED, AND MANUALLY INSERTED THE APPROPRIATE LOCKING SCREWS WITH VA SLEEVE. HOWEVER, THE SCREW HAD A PIECE OF METAL ON IT AND WAS NOT TORQUED. SIMILARLY, WHEN THE SURGEON DRILLED, MEASURED, AND INSERTED THE RELEVANT PRODUCT WITH A VA SLEEVE INTO ANOTHER HOLE, IT WAS TORQUED AND USED WITHOUT PROBLEMS. THE SURGEON COMMENTED THAT IT HAPPENED BECAUSE THE SCREW WENT IN AT A STRONGER OBLIQUE ANGLE THAN THE DIRECTION IN WHICH IT WAS DRILLED. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THERE WAS NO PROBLEM WITH BONE FIXATION. THERE WAS NO SURGICAL DELAY IN RELATION TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632015 ↗
• InjurySep 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY TREATING THE CLAVICLE. AFTER SURGERY, ON (B)(6) 2022, IT WAS REPORTED THAT THE SCREWS BROKE. A REVISION SURGERY IS PLANNED ON (B)(6) 2022. IN THE REVISION SURGERY, BROKEN IMPLANTS WILL BE EXTRACTED, AND A LONG PLATE WILL BE USED FOR TREATMENT. THIS REPORT INVOLVES ONE 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15417143 ↗

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