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LCP 226.591Recalls & reported problems

Synthes GmbH · 4.5MM BROAD LCP® PLATE 9 HOLES/170MM · Class 2 · Implant

All models of LCP (367)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982159090), received between Mar 22, 2018 and Dec 24, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Material Twisted/Bent1

Patient problems

  • No Code Available2
  • No Clinical Signs, Symptoms or Conditions1
  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 24, 2020Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2020, 3 PLATES WERE STRIPPED, AND LOCKING SCREWS DID NOT LOCK INTO THE PLATES. THE PLATES IN QUESTION WERE 4.5MM BROAD LCP® PLATE 9 HOLES/170MM, 4.5MM BROAD LCP® PLATE 10 HOLES/188MM, AND 4.5MM BROAD LCP® PLATE 11 HOLES/206MM. THE PROCEDURE WAS COMPLETED USING ANOTHER SET OF IMPLANTS. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR 1 4.5MM BROAD LCP® PLATE 9 HOLES/170MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11072250 ↗
  • InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A NARROW LARGE FRAG PLATE WITH 8 SCREWS IN THE RIGHT HUMERAL SHAFT AND 1/3 TUBULAR PLATE WITH 5 SCREWS FROM THE ANTERIOR OF THE HUMERAL SHAFT TO TREAT NON-UNION. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 MM BROAD LCP® PLATE 9 HOLES/ 170 MM. (B)(4).

    Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

    MAUDE report 9678182 ↗
  • InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A REVISION SURGERY ON (B)(6) 2018 FOR REMOVAL OF 4.5MM BROAD LOCKING COMPRESSION PLATE (LCP) 9 HOLES/170MM AND UNKNOWN SCREWS IMPLANTED ON (B)(6) 2013. THE REVISION SURGERY WAS CARRIED OUT AS THE PATIENT HAD THE COMPLAINT OF SENSITIVITY TO THE PLATE ON THE HUMERUS. DURING THE REVISION SURGERY ONE 4.5MM BROAD LCP PLATE 9 HOLES/170MM AND TEN UNKNOWN SCREWS WERE REMOVED INTACT. NOTHING WAS IMPLANTED AFTER REMOVAL OF PLATE AND SCREWS. SUCCESSFUL UNION OF FRACTURE HAD OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) 4.5MM BROAD LCP® PLATE 9 HOLES/170MM. (B)(4).

    Patient problems: No Code Available

    MAUDE report 7361521 ↗

Other Screw, fixation, bone devices

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Sources and updates

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