BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANT

    MDR report key: 1592196 · Received February 1, 2010

    Report

    Report Number
    1030489-2010-00115
    Event Type
    Injury
    Date Received
    February 1, 2010
    Date of Event
    July 27, 2009
    Report Date
    January 4, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MRW
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNK IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN "AXIAL LUMBAR INTERBODY FUSION" FROM L5-S1 USING PEDICLE SCREW FIXATION. THE PT HAD A NON-UNION OF FACET SCREW FIXATION AT L5-S1 WITH CONTINUED COMPLAINTS OF LOW BACK PAIN, RIGHT LEG PAIN, AND NUMBNESS AND TINGLING IN THE RIGHT LEG AS WELL AS WEAKNESS. CT SCANS, MRI AND X-RAYS WERE DONE. APPROX 4 MONTHS POST-OP, THE PT UNDERWENT A REVISION PROCEDURE WITH PEDICLE SCREW FUSION AND REMOVAL OF THE BILATERAL FACET SCREWS. THE PT CONTINUES TO COMPLAIN OF LOW BACK PAIN AND RIGHT LEG PAIN WITH NUMBNESS/TINGLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANT FACET SCREW MRW WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention MASTERGRAFT MATRIX| INFUSE BONE GRAFT, SMALL KIT| ERITHROM, 2CCS