BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L STOP ADJUST F/TRIAL IMPL

    MDR report key: 3133074 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02673
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    December 13, 2010
    Report Date
    December 20, 2010
    Manufacturer
    SYNTHES USA
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORD WILL NOT BE PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. THE ADDITIONAL EVALUATION REVEALED THAT THE ADJUSTABLE STOP BROKE OFF IN THE TRIAL IMPLANT. THE INVESTIGATION HAS SHOWN THAT ALL RETURNED ARTICLES ARE INDEED BADLY DAMAGED. THE STOP IS SNAPPED OFF. PLEASE NOTE THAT THESE ARE OLD AND OFTEN USED INSTRUMENTS. THE CONDITION OF THE INSTRUMENT PROVES THAT. THEREFORE, WE DETERMINE THE COMPLAINED MALFUNCTION AS NORMAL WEAR AND TEAR CAUSED DUE TO FREQUENT USE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DURING A L4-L5 TOTAL DISC REPLACEMENT THE HANDLE OF THE TRIAL IMPLANTS GOT STUCK AND DOCTOR WAS UNABLE TO REMOVE IT FROM THE TRIAL IMPLANT IN ORDER TO USE THE KEEL IN THE NEXT STEP. THE DOCTOR HAD TO REMOVE THE HANDLE ALONG WITH THE TRIAL IMPLANT AND ENDED UP ONLY USING THE TRIAL IMPLANT WITHOUT HANDLE. IT WAS AS HE IMPACTED THE TRIAL IMPLANT INTO THE DISC SPACE THE ADJUSTABLE STOP BROKE OFF IN THE TRIAL IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234177 PRODISC-L STOP ADJUST F/TRIAL IMPL MJO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1