BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1083832 · Received July 25, 2008

    Report

    Report Number
    1030489-2008-00382
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    January 25, 2007
    Report Date
    January 25, 2007
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 MANUFACTURING 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 PATIENT COMPLICATIONS. NEVERTHELESS, WE ARE FILING AN MDR FOR NOTIFICATION PURPOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE USING INTERBODY DEVICE. THE DEVICE WAS BROKEN DURING IMPACTION. THE BROKEN PIECES WERE RETRIEVED. THE BROKEN DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB PLACEMENT MQP SOFAMOR DANEK DEGGENDORF GMBH NA LQ96

    Patients

    Seq Age Sex Outcome Treatment
    1