LCP 241.095SRecalls & reported problems
Synthes GmbH · 3.5MM LCP CLAVICLE HOOK PL 6H 15MM HOOK DEPTH/73MM/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 10886982165848), received between Sep 13, 2021 and Sep 21, 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
- Nonunion/Delayed-union Bone Fracture1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 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 AN 3.5MM LOCKING COMPRESSION PLATE (LCP) CLAVICULAR HOOK PLATE. THERE WAS A UNION OF FRACTURE AFTER 18 WEEKS DURATION AND NO POST-OPERATIVE COMPLICATIONS REPORTED. PATIENT WAS REOPERATED AND HARDWARE WAS REMOVED AS PATIENT COULD FEEL IMPLANT. THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 6H 15MM HOOK DEPTH/73MM/LT-STER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 12506506 ↗InjurySep 13, 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 AND REPAIR OF AC JOINT SURGERY FOR A LATERAL FRACTURE UTILIZING A LCP CLAVICULAR HOOK PLATE 3.5. PLATE LCP 7 HOLE 2.7 X 67MM; FRACTURE FIXATION WAS ADDED IN SURGERY. FOR UNKNOWN REASON, REOPERATION FOR HARDWARE REMOVAL WAS REPORTED. THERE WAS NO UNION OF FRACTURE REPORTED. PATIENT WAS REPORTEDLY DID NOT FOLLOW POSTOPERATIVE INSTRUCTIONS AND PERFORMED UNRESTRICTED ROM IMMEDIATELY FOLLOWING SURGERY, ENDED HAVING AN AC RECONSTRUCTION BY SPORTS MED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP CLAVICLE HOOK PL 6H 15MM HOOK DEPTH/73MM/LT-STER. THIS IS REPORT 1 OF 11 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12460666 ↗
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page