BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1083814 · Received July 25, 2008

    Report

    Report Number
    1030489-2008-00392
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    September 26, 2007
    Report Date
    September 26, 2007
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    K041556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS RETURNED TO THE MFR WHERE EVALUATION CONFIRMED THE BREAKAGE OF THE DEVICE. NO EVIDENCE WAS NOTED OF MFG NON-CONFORMANCE OR DESIGN RELATED ISSUES DURING PRODUCT ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE IMPLANT BREAKAGE DID NOT RESULT IN PT COMPLICATIONS. NEVERTHELESS, WE ARE FILLING AN MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE USING INTERBODY DEVICE. THE DEVICE WAS BROKEN DURING IMPACTION. THE BROKEN DEVICE WAS REPLACED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB REPLACEMENT MQP SOFAMOR DANEK DEGGENDORF GMBH NA MF27

    Patients

    Seq Age Sex Outcome Treatment
    1