LCP 02.112.031Recalls & reported problems
Synthes GmbH · 3.5MM LCP SUP ANT CLAVICLE PLATE 8H/LT/120MM · Class 2 · Implant
All models of LCP (367)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982032898), received between Jun 30, 2021 and Sep 13, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Numbness1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 FOR A SHAFT FRACTURE UTILIZING AN LCP SUPERIOR-ANTERIOR CLAVICLE PLATE. POSTOPERATIVELY, THE PATIENT EXPERIENCED HAND NUMBNESS. THERE WAS A UNION OF FRACTURE IN ABOUT 12 WEEKS DURATION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5MM LCP SUP ANT CLAVICLE PLATE 8H/LT/120MM. THIS REPORT IS 1 OF 10 FOR (B)(4).
Patient problems: Numbness
MAUDE report 12464835 ↗MalfunctionJun 30, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, THE LOCKING COMPRESSION PLATE (LCP) ANTERIOR CLAVICLE PLATE DOES NOT FIT PROPERLY. THE SURGEON HAD TO PERFORM MULTIPLE BENDS IN ORDER TO MAKE THE PLATE FIT. THERE WAS A TEN (10) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE BENDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12096034 ↗
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- PRECICE® Plating System LP4.5-PRT42Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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