LCP 04.112.108Recalls & reported problems
Synthes GmbH · 2.7MM/3.5MM TI LCP POSTLAT DSTL FIBULA PL 4H/RIGHT/90MM · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 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 10886982103147), received between Apr 13, 2023 and Apr 13, 2023 — 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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6)2022, THE PATIENT UNDERWENT AN ORIF PRIMARY SURGERY TREATING FIBULA USING THE DFP PLATE IN QUESTION ON POSTEROLATERAL. THE PLATE FRACTURED 3 MONTHS AFTER SURGERY. IT BROKE FROM THE MOST DISTAL PART OF THE PLATE WHERE THE 4TH AND 5TH SCREWS WERE INSERTED. THE 4TH AND 5TH SCREWS WERE INSERTED THROUGH THE FRACTURE SITE. THE SURGEON REPORTED THE PATIENT BOYCOTTED HIS 2-MONTH FOLLOW-UP, AND A FRACTURE WAS DISCOVERED AT THE 3-MONTH FOLLOW-UP. THE PATIENT HAD A NON-UNION, AND AS A RESULT OF STRESS CONCENTRATION AT THE SCREW INSERTION SITE JUST ABOVE THE FRACTURE SITE, IT MAY HAVE LED TO PLATE FRACTURE.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 16735493 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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