BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02315

    MDR report key: 3183611 · Received June 22, 2013

    Report

    Report Number
    2520274-2013-02315
    Event Type
    Injury
    Date Received
    June 22, 2013
    Report Date
    April 4, 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. THIS REPORT IS FOR 2 UNKNOWN SCREWS.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS PERFORMED AND STATES THE FOLLOWING: THE DEVICE WAS SENT TO OUR PRODUCT DEVELOPMENT CENTER FOR FURTHER INVESTIGATION. ACCORDING TO THE STATEMENT THE ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE IMPLANT WAS FULLY DISASSEMBLED. IT WAS ESTABLISHED, THAT THE CLAMPING RING IS BENT WHICH BLOCKS THE TELESCOPING FEATURE. BECAUSE OF THE DIRECTION OF THE BENDING OF THE CLAMPING RING, THIS IS AN INDICATION THAT THE LOCKING SCREW WAS BENT WHILE THE PROCEDURE OF DISSOLVING. THIS WAS CAUSED BY EXCESSIVE TIGHTENING OF THE LOCKING SCREW. THE REVIEWS OF THE MANUFACTURING AND MATERIAL DOCUMENTS SHOW NO DEVIATION ACCORDING TO THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PATIENT WAS IMPLANTED WITH PERFORATED MATRIX SCREWS DURING A SURGERY ON (B)(6) 2013. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE SCREWS WERE IN A FAULTY POSITION. A REVISION SURGERY WAS CONDUCTED. DURING THE REVISION SURGERY ON (B)(6) 2013, A LOCKING CAP COULD NOT BE SOLVED. THE SURGEON USED A BOLT CUTTER. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR TWO UNKNOWN SCREWS. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284205 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention