LCP 241.083SRecalls & reported problems
Synthes GmbH · 3.5MM LCP CLAVICLE HOOK PL 5H 12MM HOOK DEPTH/59MM/LT-STER · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982165787), received between Aug 31, 2021 and Sep 20, 2021 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Skin Inflammation/ Irritation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 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 LATERAL FRACTURE FIXATION AND REPAIR OF AC JOINT UTILIZING A LCP CLAVICULAR HOOK PLATE 3.5. HARDWARE REMOVAL WAS DONE AS PATIENT COULD FEEL THE IMPLANT. THERE WAS A UNION OF FRACTURE FOR ABOUT 20 WEEKS DURATION AND NO POST-OPERATIVE COMPLICATIONS REPORTED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) 3.5MM LCP CLAVICLE HOOK PL 5H 12MM HOOK DEPTH/59MM/LT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 12502615 ↗InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING A LCP CLAVICULAR HOOK PLATE 3.5. REOPERATION WAS DUE TO HARDWARE REMOVAL AND THE PATIENT COULD FEEL IMPLANT. NO POST-OPERATIVE COMPLICATIONS REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: CORTEX (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 5) THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 5H 12MM HOOK DEPTH/59MM/LT-STER. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 12393483 ↗
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- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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