LCP 02.112.007Recalls & reported problems
Synthes GmbH · 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM · 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 10886982032577), received between Sep 10, 2021 and Nov 22, 2022 — 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.
InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS BROUGHT TO THE OR FOR REMOVAL OF A CLAVICLE PLATE WITH NONUNION AND REVISION WITH A TIBIAL TUBERCLE BONE GRAFT AND HOOK PLATE. ALL HARDWARE WAS INTACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM. THIS IS REPORT 1 OF 9 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15842596 ↗InjurySep 10, 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 FOR A FRACTURE REMOVAL SURGERY FOR A SHAFT FRACTURE UTILIZING AN LCP SUPERIOR-ANTERIOR CLAVICLE PLATE. THERE WAS A UNION OF FRACTURE AFTER 12 WEEKS DURATION. 1 YEAR POSTOPERATIVELY, HARDWARE REMOVAL WAS REPORTED DUE TO PATIENT COULD FEEL THE IMPLANT. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: CORTEX (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 6). THIS COMPLAINT INVOLVES SEVEN(7) DEVICES. THIS REPORT IS FOR (1)3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM. THIS REPORT IS 1 OF 7 FOR (B)(4).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 12456498 ↗
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- 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.
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