BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02472

    MDR report key: 3101786 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02472
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    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

    X-RAY DATES - PREOPERATIVELY TAKEN ON (B)(6) 2013 AND POSTOPERATIVELY TAKEN ON (B)(6) 2012 NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE UNKNOWN PLATE FROM AN UNKNOWN LOT.

    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 2 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES GMBH 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 2 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203707 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention