LCP 02.112.084Recalls & reported problems
Synthes GmbH · 3.5MM LCP SUPERIOR CLAVICLE PLATE/8 HOLE/RIGHT/115MM · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982033178), received between Nov 20, 2018 and Mar 29, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Slipped1
Patient problems
- Failure of Implant2
- Bone Fracture(s)1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF CLAVICLE DUE TO NONUNION. THE LOCKING COMPRESSION PLATE 8-HOLE THAT WAS PREVIOUSLY IMPLANTED BROKE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5MM LCP SUPERIOR CLAVICLE PLATE/8 HOLE/RIGHT/115MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 8464590 ↗InjuryNov 20, 2018Device Slipped; Device Slipped
IT WAS NOTED THAT AT THE TIME OF THE REVISION PROCEDURE, THE CLAVICLE FRACTURE WAS NOT HEALED.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 8092328 ↗
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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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