LCP 02.112.115Recalls & reported problems
Synthes GmbH · 2.7MM/3.5MM LCP POSTLAT DISTAL FIBULA PLATE 7H/LEFT/129MM · Class 2 · Implant
All models of LCP (367)
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 10886982033512), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER QUALITY UNIT RECEIVED A USER FACILITY REPORT FORWARDED FROM (B)(6) HOSPITAL; THIS REPORT IS AGAINST USER FACILITY MEDWATCH REPORT # (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE USER FACILITY EVENT REPORT IS ATTACHED. IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE IN WHICH THE 2.7MM/3.5MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL FIBULA PLATE AND THIRTEEN (13) SCREWS FOR A CLAVICLE FRACTURE ON (B)(6) 2017. ON UNKNOWN DATE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ELEVEN (11) OF THE SCREWS AND THE PLATE. IT IS UNKNOWN WHY TWO (2) OF THE SCREWS REMAIN IMPLANTED. SURGERY WAS COMPLETED. PATIENT STATUS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM LCP POSTEROLATERAL DISTAL FIBULA PLATE THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Unspecified Infection
MAUDE report 7432793 ↗
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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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