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LCP 223.414Recalls & reported problems

Synthes GmbH · 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES · Class 2 · Implant

Data updated Oct 13, 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 10886982157652), received between Jan 5, 2023 and Jan 6, 2023 — classified as 2 injuries.

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

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Nonunion/Delayed-union Bone Fracture1
  • Physical Asymmetry1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: SUBJECT: (B)(4). AE2: POSTOPERATIVE ADVERSE EVENT: " NONUNION ". IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES". IS THE AE RELATED TO THE DEVICE? "YES". DPS IMPLANT WAS USED. THIS REPORT IS FOR A 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES. THIS IS REPORT 1 OF 12 FOR (B)(4).

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 16116225 ↗
  • InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: SUBJECT (B)(6). POSTOPERATIVE ADVERSE EVENT: " OTHER AE RELATED TO THE PROCEDURE OR IMPLANT: VALGUS COMPARED TO CONTRALATERAL; COULD INFLUENCE STABILITY AND FUNCTION. " IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES." IS THE AE RELATED TO THE DEVICE? "YES." DPS IMPLANT WAS USED. THIS REPORT IS FOR A 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES. THIS IS REPORT 1 OF 12 FOR (B)(4).

    Patient problems: Physical Asymmetry

    MAUDE report 16106461 ↗

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

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Sources and updates

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