LCP 241.105SRecalls & reported problems
Synthes GmbH · 3.5MM LCP CLAVICLE HOOK PL 7H 15MM HOOK DEPTH/86MM/LT-STER · 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 10886982165886), received between Sep 17, 2021 and Sep 17, 2021 — 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
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A LATERAL FRACTURE UTILIZING LCP CLAVICULAR HOOK PLATE 3.5. UNION WAS ACHIEVED AFTER 16 WEEKS. REOPERATION WAS DONE DUE TO HARDWARE REMOVAL; PATIENT COULD FEEL IMPLANT IRRITATION. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5 LCP CLAV HK PL 7H 15 HK DPTH/86/LT-S. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 12489552 ↗
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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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