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NA 237.42Recalls & reported problems

Synthes GmbH · 95 DEG CONDYLAR PLATE 14 HOLES/60MM/235MM · Class 2 · Implant

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 10886982161239), received between Sep 29, 2022 and Sep 29, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2022Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT A BLADE PLATE WAS PUT IN FOR A SUBTROCH FRACTURE AND THE PLATE FAILED REQUIRING REVISION SURGERY. DURING THE ORIGINAL SURGERY THE TEAM THOUGHT THEY PUT IN A DIFFERENT SIZE BLADE PLATE THAN THEY DID. THEY THOUGHT THEY PUT AN 80MM IN BUT AFTER REMOVING THE IMPLANT THEY FOUND THEY PUT A 60MM BLADE IN. PATIENT CONSEQUENCE WAS REPORTED. PATIENT CONSEQUENCE DESCRIPTION/ CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.): REVISION SURGERY. THIS REPORT IS FOR ONE (1) CONDYL-PL 95° 14HO L236 BLADE60 SST THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Failure of Implant

    MAUDE report 15501431 ↗

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

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

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