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LC-DCP 226.62Recalls & reported problems

Synthes (U.S.A.) LP · 4.5MM BROAD LC-DCP® PLATE 12 HOLES/214MM · Class 2 · Implant

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 10886982159144), received between Jun 24, 2020 and Jun 24, 2020 — 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

  • Bone Fracture(s)1
  • 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.

  • InjuryJun 24, 2020Adverse 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 EXPERIENCED POST-OP NONUNION AND UNDERWENT HARDWARE REMOVAL. ON (B)(6) 2020 THE SURGEON PERFORMED A BONE GRAFT HARVEST FROM THE LEFT FEMUR TO BONE GRAFT A LEFT HUMERAL SHAFT NON-UNION. THE SURGEON REMOVED A 12 HOLE 4.5 LC-DCP BROAD PLATE AND 12 CORTEX SCREWS FROM THE NON-UNION SITE AND THEN USED THE RIA 2 SYSTEM ON THE LEFT FEMUR TO HARVEST BONE GRAFT. THE SURGEON ENTERED THE REAMER HEAD INTO THE FEMORAL CANAL AND RESISTANCE OCCURRED IN THE PROXIMAL THIRD FEMORAL CANAL. THE SURGEON RETRACTED THE REAMER HEAD AND THEN ADVANCED IT SEVERAL TIMES AND ON THE LAST RETRACTION NOTICED THE REAMER HEAD HAD COME OFF OF THE DRIVE SHAFT FOR REAMER IRRIGATOR ASPIRATOR (RIA 2). THE DOCTOR WAS ABLE TO RETRIEVE THE REAMER HEAD AND NOTICED THAT THREE FRAGMENTS FROM THE REAMER HEAD HAD BROKEN OFF. THE SURGEON WAS ABLE TO RETRIEVE TWO OF THE FRAGMENTS, BUT ONE FRAGMENT REMAINED IN THE SOFT TISSUE. ONCE THE TWO FRAGMENTS WERE REMOVED, HE USED THE RIA SYSTEM WITH A 12MM HEAD TO COMPLETE THE BONE HARVEST. THE SURGEON THEN IMPLANTED A 12 HOLE 4.5 LCP BROAD PLATE AND THE HARVESTED BONE GRAFT TO THE HUMERUS. THE DRIVE SHAFT WAS DIFFICULT TO REMOVE FROM THE

    Patient problems: Bone Fracture(s); No Code Available

    MAUDE report 10188616 ↗

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Sources and updates

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