BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1870942 · Received October 7, 2010

    Report

    Report Number
    1030489-2010-01309
    Event Type
    Injury
    Date Received
    October 7, 2010
    Report Date
    August 28, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    REVIEW OF MULTIPLE RADIOGRAPHIC IMAGES SHOW MODIC CHANGES MOST PRONOUNCED AT L2-3 WITHOUT STENOSIS. MILD DISC NARROWING NOTED AS WELL. SOME CHANGES NOTED A L1-2 AND L4-5. NO CENTRAL STENOSIS NOTED AT ANY LEVEL. TLIF DONE AT L1-2 AND L2-3 PLACED L1, L2, AND L3 ROOTS IN DANGER DURING SCREW PLACEMENT. NIM NEEDLES WERE NOT USED ABOUT L5 ROOT AND WOULD NOT SHOW DEFICIT CREATED INTER-OP DURING DECOMPRESSION AT THESE LEVELS. MANY SYMPTOMS AND REPORTED SIGNS NOT CONSISTENT WITH X-RAYS OR OPERATIVE LEVELS AS SOURCE OF PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TWO LEVEL TLIF USING POSTERIOR FIXATION AND INTERBODY DEVICES. THE PT EXPERIENCED WEAKNESS AND DRASTICALLY REDUCED POWER POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK MAX MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other IMPLANTED:| EXPLANTED:| EXPLANTED:| CAPSTONE SPINAL SYSTEM,| IMPLANTED:| POSTERIOR FIXATION