BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 1953116 · Received January 7, 2011

    Report

    Report Number
    1030489-2011-00025
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MBP
    PMA / PMN Number
    K081950
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # 1423120043, LOT # 1433190060, LOT# 1423120040, AND LOT # 1423120039. EXPIRATION DATE FOR LOT 1423120043 IS 08/16/2012; EXPIRATION DATE FOR LOT 1433190060 IS 09/08/2012; EXPIRATION DATE FOR LOT 1423120040 IS 08/16/2012; EXPIRATION DATE FOR LOT 1423120039 IS 08/16/2012. MANUFACTURE DATE FOR LOT 1423120043 IS 08/13/2010; MANUFACTURE DATE FOR LOT 1433190060 IS 09/07/2010; MANUFACTURE DATE FOR LOT 1423120040 IS 08/13/2010; MANUFACTURE DATE FOR LOT 1423120039 IS 08/13/2010. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-S1 FUSION. THE PROCEDURE INFORMATION WAS THAT L3-S1 LAMINECTOMIES WITH L4-S1 BILATERAL OSTEOTOMIES AND DISKECTOMIES WITH INTERBODY FUSION WITH PEEK CAGE WITH AUTO AND ALLOGRAFT BONE AND MORPHOGENIC PROTEIN AS WELL AS L4-S1 PEDICLE SCREW FUSION AND RESTORATION OF NORMAL SPINAL ALIGNMENT WITH AUTO AND ALLOGRAFT BONE AND BMP WITH INTRAOPERATIVE MICROSCOPY, INTRAOPERATIVE FLUOROSCOPY, INJECTION OF INTRATHECAL DURAMORPH, IMPLANTATION OF 2 INTRAMUSCULAR PAIN PUMPS THROUGH 2 SEPARATE. STAB INCISIONS AND INTRAOPERATIVE MONITORING OF BASELINE ELECTROGRAMS WITH CONTINUOUS ELECTROMYOGRAM MONITORING THROUGHOUT THE CASE. AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENIX DBM PUTTY FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1