BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG PEEK FUSION DEVICE

    MDR report key: 1961781 · Received January 14, 2011

    Report

    Report Number
    1030489-2011-00046
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR USE IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9170730, 510K # K030601 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    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 # SU63, EXPIRATION DATE 5/26/2018 AND LOT # PM28, EXPIRATION DATE 10/31/2016. MANUFACTURE DATE FOR LOT SU63 IS 4/20/2010; MANUFACTURE DATE FOR LOT PM28 IS 9/17/2008. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH LOTS DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION, THE INTERBODY DEVICE BROKE IN THE INTERVERTEBRAL SPACE (L4-L5). THE BROKEN PIECE WAS LEFT IN PLACE BECAUSE IT WAS TOO COMPLICATED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG PEEK FUSION DEVICE MQP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Other