BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1083830 · Received July 25, 2008

    Report

    Report Number
    1030489-2008-00383
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    February 16, 2007
    Report Date
    February 16, 2007
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MQP
    PMA / PMN Number
    K041556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERBODY DEVICE "SPLIT SIDE TO SIDE IN SURGERY". THE IMPLANT WAS REPLACED. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB PLACEMENT MQP WARSAW ORTHOPEDIC INC. NA KW90

    Patients

    Seq Age Sex Outcome Treatment
    1