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DCS 281.980Recalls & reported problems

Synthes GmbH · 95 DEG DCS® PLATE 8 HOLES/146MM · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982178121), received between May 4, 2018 and Jan 12, 2022 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Break1

Patient problems

  • Bone Fracture(s)2
  • Failure of Implant1
  • 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.

  • InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2021, A FRACTURE OCCURRED ABOVE A SYNTHES DCS CONSTRUCT. THE HARDWARE WAS SUCCESSFULLY REMOVED AND A FEMORAL RECON NAIL WAS PLACED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) UNK - NAIL HEAD ELEM: DHS/DCS. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

    Patient problems: Bone Fracture(s)

    MAUDE report 13238058 ↗
  • InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2021, A FRACTURE OCCURRED ABOVE A SYNTHES DCS CONSTRUCT. THE HARDWARE WAS SUCCESSFULLY REMOVED AND A FEMORAL RECON NAIL WAS PLACED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 95 DEG DCS PLATE 8 HOLES/146MM. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

    Patient problems: Bone Fracture(s)

    MAUDE report 13238057 ↗
  • InjuryMay 4, 2018Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH THE 95 DEGREE DYNAMIC CONDYLAR SCREW (DCS) PLATE ON (B)(6) 2018. POSTOPERATIVELY THE PLATE BROKE IN THE PATIENT. POSTOPERATIVELY ON AN UNKNOWN DATE THE PATIENT UNDERWENT IMMEDIATE SURGICAL TREATMENT OF CONSOLIDATION DELAY AND PROXIMAL FEMUR REFRACTION (DCS FAILURE) WITHOUT INTERCURRENCES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 7486756 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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