NA 04.112.912SRecalls & reported problems
Synthes GmbH · 2.7MM TI VA LCP BUTTON HOOK PLATE/ 12MM/ LEFT/ STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982279781), received between Apr 2, 2025 and May 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Migration2
Patient problems
- Discomfort1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Migration; Migration
SUBJECT ID: (B)6). STUDY NO: NO INFORMATION PROVIDED. CLINICAL ADVERSE EVENT RECEIVED FOR POSTOPERATIVE ADVERSE EVENT: "PAIN/DISCOMFORT/PROMINENCE". IS THE AE RELATED TO THE IMPLANTATION OR EXPLANTATION OF THE HOOK PLATE? YES. IS THE AE RELATED TO THE INVESTIGATIONAL DEVICE (VA CLAVICLE PLATE/VA CLAVICLE HOOK PLATE)? NO. IS THE AE RELATED TO THE CONDITION UNDER INVESTIGATION? NO. DATE OF EVENT: 04 APRIL 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: ANALGESICS ADMINISTERED (TILIDIN, PARACETAMOL), REMOVAL OF HARDWARE ON (B)(6) 2025.
Patient problems: Discomfort; Pain
MAUDE report 22073036 ↗MalfunctionApr 2, 2025Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A PRIMARY SURGERY WITH THE VA-LCP CLAVICLE HOOK PLATE IN QUESTION. THE SURGEON CONFIRMED THAT THE HEIGHT OF THE HOOK AND INSTALLATION POSITION WERE APPROPRIATE. HOWEVER, THE X-RAY IN MARCH SHOWED THAT THE HOOK APPEARED TO SLIDE ANTERIOR AND WAS ABOUT TO DISLOCATE.
Patient problems: Insufficient Information
MAUDE report 21753033 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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