NA 04.112.915SRecalls & reported problems
Synthes GmbH · 2.7MM TI VA LCP BUTTON HOOK PLATE/ 15MM/ RIGHT/ STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982279828), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH THE PLATE IN QUESTION FOR ACROMIOCLAVICULAR DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THREE WEEKS AFTER SURGERY, IT WAS CONFIRMED THAT THE PLATE IN QUESTION WAS DAMAGED. ON (B)(6) 2024, A REMOVAL AND REVISION SURGERY WAS SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCP BUTTON HOOK PLATE/ 15MM/ RIGHT/ STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4).
Patient problems: Insufficient Information
MAUDE report 20238741 ↗
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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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