LCP 02.104.006Recalls & reported problems
Synthes GmbH · 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 6H/RT 158MM LONG · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982029003), received between Aug 1, 2017 and Aug 1, 2017 — classified as 1 injury.
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 Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH ONE 3.5MM LOCKING COMPRESSION (LCP) EXTRA-ARTICULAR DISTAL PLATE (RIGHT), ANOTHER UNKNOWN PLATE, AND AN UNKNOWN NUMBER OF UNKNOWN CORTICAL AND LOCKING SCREWS ON AN UNKNOWN DATE IN 2017 TO TREAT AN UNKNOWN HUMERUS FRACTURE. POSTOPERATIVELY, APPROXIMATELY FOUR MONTHS AFTER THE INITIAL IMPLANT, THE PATIENT SUFFERED ANOTHER FRACTURE OF THE HUMERUS DIRECTLY ABOVE THE PREVIOUS FRACTURE SITE WHILE THROWING A FOOTBALL. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE ONE (1) OF THE PLATES, FOUR (4) CORTICAL SCREWS, AND FIVE (5) LOCKING SCREWS WERE REMOVED INTACT. THE SURGEON ELECTED TO LEAVE THE REMAINING PLATE AND SCREWS IN THE PATIENT, IT IS UNKNOWN WHY. IN PLACE OF THE EXPLANTED DEVICES, THE PATIENT WAS IMPLANTED WITH A 14-HOLE 4.5MM/3.5MM LCP® METAPHYSEAL PLATE, FIVE (5) 3.5MM LOCKING SCREWS, ONE (1) 3.5MM CORTICAL SCREW, ONE (1) 2.45MM CORTICAL SCREW, AND ONE (1) 5.0MM LOCKING SCREW ON (B)(6) 2017 TO TREAT THE NEW FRACTURE. THERE WERE NO SURGICAL DELAYS REPORTED AND THE PATIENT STATUS AT THE TIME OF THE REPORT. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING COMPRESSION (LCP) EXTRA-ARTICULAR DISTAL PLATE. THIS IS REPORT 1
Patient problems: No Code Available
MAUDE report 6757378 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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