BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03469

    MDR report key: 3170036 · Received June 14, 2013

    Report

    Report Number
    2520274-2013-03469
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE INFORMATION RECEIVED ON 8/19/2013, IT WAS DETERMINED THAT SYNTHES IS NOT THE LEGAL MANUFACTURE OF THE COMPLAINED DEVICE; THEREFORE, SYNTHES IS RETRACTING MED WATCH REPORT NUMBER (B)(4). PLACEHOLDER.

    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) ON (B)(6) 2013, REPORTEDLY THE SPACER BROKE AS THE SURGEON WAS USING THE IMPACTOR TO SET THE SPACER DEEPER. THE SPACER WAS REMOVED AND REPLACED. LESS THAN FIFTEEN MINUTES WAS ADDED TO THE PROCEDURE DUE TO THIS EVENT. THIS REPORT IS FOR AN UNKNOWN SPACER. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270810 MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1