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NA 237.76Recalls & reported problems

Synthes GmbH · 95 DEG CONDYLAR PLATE 7 HOLES/80MM/124MM · Class 2 · Implant

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 10886982161499), received between Sep 11, 2024 and Sep 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Break1

Patient problems

  • Nonunion/Delayed-union Bone Fracture1
  • Pain1

Recent adverse event reports

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

  • InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 64 PATIENTS THAT WERE IMPLANTED WITH ANGLED BLADE PLATES. IMPLANTATION WAS BETWEEN (B)(6) 2000 TO (B)(6) 2023 AT THE (B)(6). REASON FOR IMPLANTATION FRACTURE FIXATION. POST OP COMPLICATION PATIENT DESCRIBES PAIN IN THE ANTERIOR ASPECT OF THE MID-THIGH. TREATMENT/INTERVENTION INCLUDED HARDWARE REMOVAL. IMPLANT(S) INVOLVED: 95 DEG CONDYLAR PLATE 7 HOLES/80MM/124MM X 1. CORTEX SCREWS X 5.

    Patient problems: Pain

    MAUDE report 20193116 ↗
  • InjurySep 11, 2024Break; Break

    THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 64 PATIENTS THAT WERE IMPLANTED WITH ANGLED BLADE PLATES. IMPLANTATION WAS BETWEEN (B)(6) 2000 TO (B)(6) 2023 AT THE UNIVERSITY OF (B)(6). REASON FOR IMPLANTATION WAS PERITROCHANTERIC FRACTURE FIXATION. POST OP COMPLICATION INCLUDED PLATE AND SCREW BREAKAGE. TREATMENT/INTERVENTION INCLUDED PLATE AND SCREWS REMOVED AND NONUNION REPAIRED WITH REVISION NAIL. IMPLANT(S) INVOLVED: 95 DEG CONDYLAR PLATE 7 HOLES/80MM/124MM X 1. CORTEX SCREWS X 4. THIS REPORT IS FOR ONE (1) 95 DEG CONDYLAR PLATE 7 HOLES/80MM/124MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 20192038 ↗

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.