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LCP 226.571Recalls & reported problems

Synthes GmbH · 4.5MM BROAD LCP® PLATE 7 HOLES/134MM · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982159052), received between Oct 18, 2019 and Mar 17, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Twisted/Bent2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Code Available1

Recent adverse event reports

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

  • MalfunctionMar 17, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, ONE (1) BROAD LOCKING COMPRESSION PLATE HOLE STRIPPED AND THE LOCKING HOLE DID NOT ENGAGE, ONE (1) BROAD LOCKING COMPRESSION PLATE BROKE AFTER EXCESSIVE BENDING, AND THE PINS OF A EIGHT (8) SHANZ SCREW BLUNTED TROCAR POINT HAD A BROKEN TIPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THREE (3) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 4.5MM BROAD LCP PLATE 7 HOLES/134MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11504648 ↗
  • MalfunctionDec 29, 2020Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2020, THE VARIABLE ANGLE LOCKING COMPRESSION PLATE HOLES WERE STRIPPED, A VARIABLE ANGLE CONE WAS USED IN THE VA DISTAL FIBULA PLATES, AND A LOCKING DRILL TOWER IN THE LARGE FRAGMENT PLATE. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/3 HOLES/LEFT (PART NUMBER 02.118.401, LOT UNKNOWN, QUANTITY 1), 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/LEFT (PART NUMBER 02.118.405, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 4.5MM BROAD LCP® PLATE 7 HOLES/134MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11088309 ↗
  • InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AND TOTAL FEMORAL REPLACEMENT DUE TO A FAILED TOTAL KNEE ARTHROPLASTY WHICH REQUIRED A TUMOR RESECTION ON (B)(6) 2019. ORIGINALLY THE PATIENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2019, THE PATIENT REPORTED DIFFICULTY BEARING WEIGHT ON LEFT LEG AND WAS DIAGNOSED WITH A LEFT FEMUR LYTIC LESION. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 MM BROAD LCP® PLATE 7 HOLES/134 MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 9209945 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.