BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASIS¿ SPINAL SYSTEM

    MDR report key: 2661493 · Received July 19, 2012

    Report

    Report Number
    1030489-2012-01170
    Event Type
    Injury
    Date Received
    July 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SHOULD NOT BE A 5 DAY REPORT, THE REPORT IS A 30 DAY REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART # (B)(4), LOT 0074378W; LOT 0167380W; PART #(B)(4), LOT 0130767W; LOT 0119812W; PART (B)(4), LOT 0158271W. 510K #S: K050484, K921767. THE MANUFACTURE DATE FOR LOT 0074378W IS 12/30/2009; THE MANUFACTURE DATE FOR LOT 0167380W IS 7/12/2010; THE MANUFACTURE DATE FOR LOT 0130767W IS 12/2/2010; THE MANUFACTURE DATE FOR LOT 0119812W IS 9/29/2010; THE MANUFACTURE DATE FOR LOT 0158271W IS 5/3/2011. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL LUMBAR SURGICAL PROCEDURE. IT WAS REPORTED THAT SOMETIME POST-OP, THE PATIENT COMPLAINED OF WAIST PAIN, PAIN IN LEGS, AND LEGS TINGLING WITH INCREASED SYMPTOMS MORE RECENTLY. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIS¿ SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR RODS, SCREWS, VB REPLACMENT