BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02471

    MDR report key: 3101720 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02471
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.THIS IS THE DATE THAT IT WAS NOTICED THAT ALTHOUGH THE PART WAS REFERENCED IN THE B5 EVENT DESCRIPTION OF THE INITIAL REPORT, IT WAS NOT SPECIFIED THAT THE REPORT PERTAINS TO THE SCREW THAT BROKE.(B)(4): THIS REPORT IS FOR ONE UNKNOWN BROKEN SCREW FROM AN UNKNOWN LOT.

    Additional Manufacturer Narrative · 1

    X-RAY DATES - PREOPERATIVELY TAKEN ON (B)(6) 2013 AND POSTOPERATIVELY TAKEN ON (B)(6) 2012.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, A DYNAMIC LOCKING SCREW (DLS) SCREW MIGRATED INTRA-OPERATIVELY. AFTER THE MIGRATION IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. THE DLS SCREW WAS REMOVED AND BROKE DURING REMOVAL. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, A DYNAMIC LOCKING SCREW (DLS) MIGRATED INTRA-OPERATIVELY. AFTER THE MIGRATION IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. ADDITIONALLY, A DLS SCREW WAS BROKEN DURING REMOVAL OF THE CONSTRUCT.THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4). THIS REPORT IS FOR THE AFOREMENTIONED BROKEN SCREW, THE PART NUMBER FOR WHICH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204165 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1