BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3792571 · Received May 6, 2014

    Report

    Report Number
    2520274-2014-11290
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR 6 UNKNOWN SCREWS/UNKNOWN LOT. IMPLANT DATE: UNKNOWN DATE, UNKNOWN MONTH 2011. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN 2011 A PLATE WAS IMPLANTED WITH SIX SCREWS TO GET A STRAIGHT LEG POSITION. AFTERWARDS THE PATIENT STILL HAD A LOT OF PAIN; SO THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2013. DURING THIS SECOND SURGERY THEY FOUND OUT THAT ALL SCREWS WERE BROKEN. THIS REPORT IS FOR SIX UNKNOWN SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270214 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention