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DCS 281.900Recalls & reported problems

Synthes GmbH · 95 DEG DCS® PLATE 10 HOLES/178MM · 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 10886982177988), received between Jan 19, 2018 and Jun 11, 2018 — classified as 2 injuries.

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

  • Break2

Patient problems

  • Failure of Implant2
  • No Code Available1

Recent adverse event reports

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

  • InjuryJun 11, 2018Break; Break

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT UNDERWENT SURGERY TO REMOVE THE IMPLANTED PLATE DUE TO DEVICE BREAKAGE. CURRENT PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 95 DEG DCS® PLATE 10 HOLES/178MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 7587676 ↗
  • InjuryJan 19, 2018Break; Break

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2017 A PATIENT WAS IMPLANTED WITH A PLATE AND SCREWS FROM THE DYNAMIC CONDYLAR SCREW SYSTEM (DCS) FOR A SUBTROCHANTERIC FRACTURE OF THE RIGHT FEMUR. ON AN UNKNOWN DATE THE PLATE WAS FOUND TO BE BROKEN IN-SITU, REPORTEDLY CAUSED BY FATIGUE OF THE IMPLANTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT DID NOT SUFFER FROM ANY FALLS DURING THE POST-OP PERIOD. THERE WAS NO REPORT OF SURGICAL DELAY OR PATIENT HARM. THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: SCREWS (PART # 280.65, LOT# UNKNOWN, QUANTITY 1), SCREWS (PART # 214.060, LOT# UNKNOWN, QUANTITY 1), SCREWS (PART # 214.040, LOT# UNKNOWN, QUANTITY 1), SCREWS (PART # 214.036, LOT# UNKNOWN, QUANTITY 1), SCREWS (PART # 214.032, LOT# UNKNOWN, QUANTITY 3), SCREWS (PART # 214.030, LOT# UNKNOWN, QUANTITY 1). (B)(4).

    Patient problems: Failure of Implant

    MAUDE report 7207255 ↗

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.