BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY STENT ACCESS KIT

    MDR report key: 2874165 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01588
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    ODP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES EUROPE. REPORT RECEIVED INDICATES THAT INVESTIGATION HAS SHOWN THAT THERE IS INDEED A HAIR BLOCKED IN THE TROCAR AS COMPLAINED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6). IT WAS REPORTED THAT DURING THE OPENING OF THE VERTEBRAL BODY STENT ACCESS (VBS) KIT, THE CUSTOMER FOUND A HAIR BLOCKED IN THE TROCAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEBRAL BODY STENT ACCESS KIT VERTEBRAL BODY STENT ACCESS KIT ODP SYNTHES GMBH AMG203

    Patients

    Seq Age Sex Outcome Treatment
    1