BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL AUGMENTATION ACCESS KIT

    MDR report key: 4121011 · Received September 26, 2014

    Report

    Report Number
    3000270450-2014-10110
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    November 15, 2012
    Report Date
    December 31, 2012
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KIH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: FZX, HXG, HTW, MJG. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CLINICAL REFERENCE NUMBER: (B)(4) (VBS VERTEBRAL BODY STENTING (B)(4)). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS COMPLAINT WAS PART OF A MARKET PREFERENCE EVALUATION WHICH RECORDS THE COMPLAINT ASPECTS OF 2010 MPE RESULTS. THE VERTEBRAL BODY STENTING (VBS) WAS USED DURING A STUDY. IT WAS REPORTED THAT ON (B)(4) 2012, THE VERTEBRAL BODY STENTING (VBS) CANNULA HAS BROKEN UNDER THE PEDICLE ENTRANCE LEVEL. THE BROKEN PART OF THE CANNULA WAS LEFT IN THE VERTEBRAL BODY / PEDICLE. IT WAS REPORTED THAT THE PATIENT HAD COMPLETELY RECOVERED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601385 VERTEBRAL AUGMENTATION ACCESS KIT DISPENSER, CEMENT KIH SYNTHES SELZACH AJW301

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR