BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRO DISC - C TOTAL DISC REPLACEMENT

    MDR report key: 1639103 · Received March 22, 2010

    Report

    Report Number
    MW5015240
    Event Type
    Other
    Date Received
    March 22, 2010
    Manufacturer
    SYNTHES INC.
    Product Code
    MJO
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT CERVICAL ARTHROPLASTY. SURGEON USING A SYNTHES IMPLANT TOOL IMPLANT INSERTER. THE SYNTHES REP INSTRUCTED THE SURGICAL TECH TO INSTALL PRO DISC INTO TOOL. SURGICAL TECH PASSES INSTRUMENT TO SURGEON. SURGEON INSTALLED PRO-DISC UPSIDE DOWN. PT HAD PAIN REQUIRING RE-HOSPITALIZATION TO REMOVE PRO DISC AND RE-INSTALL CORRECTLY. DEVICE DESIGN ALLOWS IN CORRECT INSTALLATION AND LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO DISC - C TOTAL DISC REPLACEMENT SYNTHES PRO DISC MJO SYNTHES INC. 03.820.129 INSERTER

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR