BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1559807 · Received December 11, 2009

    Report

    Report Number
    1030489-2009-01163
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    September 1, 2009
    Report Date
    November 17, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS. THE SCREWS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE LIKE DEVICE CATALOG# 9791225, 9791325 510K# K061274; CATALOG# 9795215, 510K # K042922 WERE CLEARED IN THE U.S. MANUFACTURE DATE FOR LOT H08K9171, LOT H08K9173, AND LOT H08K8842 ARE 11/20/2008. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A THREE-LEVEL FUSION PROCEDURE AT C2 TO C6 USING ANTERIOR FIXATION PLATE. THE INTERBODY DEVICES WERE ALSO IMPLANTED AT C 2/3 AND C 4/5, WHERE SUBTOTAL EXCISION WAS PERFORMED. APPROX ONE MONTH POST OP, C6 SCREW WAS FOUND BACKED OUT. THE REVISION SURGERY WAS PERFORMED APPROX THREE AND A HALF MONTHS POST OP TO REVISE THE SCREW AND EXTEND THE FUSION LEVEL TO C7. THE PT REPORTEDLY DEVELOPED A SEVERE OSTEOPOROSIS. IT WAS REPORTED THAT EXTREMELY BRITTLE BONE QUALITY WAS CONFIRMED WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention FIXATION SCREW: CATALOG#: G9795215, LOT#: H08K8842| FIXATION SCREW: CATALOG#: G9791225, LOT#: H08K9171| PLATE: CATALOG# G9790067| FIXATION SCREW: CATALOG#: G9791325, LOT#: H08K9173