BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIELKE INSTRUMENTATION WITH PEDICLE SCREW

    MDR report key: 18383 · Received December 13, 1994

    Report

    Report Number
    MW1004429
    Event Type
    Injury
    Date Received
    December 13, 1994
    Date of Event
    May 25, 1990
    Report Date
    November 22, 1994
    Manufacturer
    STUART DRUG & SURGICAL SUPPLY, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DECOMPRESSION OFF LATERAL RECESSES L4-5, L5-S1 BILATERALLY AS WELL AS BILATERAL FORAMENOTIMIES L4-5, L5-S1, NEUROLYSIS OF L5 NERVE ROOTS BILATERALLY, INSTRUMENTATION WITH PEDICLE SCREW FIXATION FROM L4 TO S12 WITH BILATERAL POSTEROLATERAL FUSION, BONE GRAFT HARVESTED FROM LEFT ILIAC CREST. LATERAL RECESS AND FORAMINAL STENOSIS AT L4-5 AND L5-S1 AND DEGENERATIVE DISC. PREOP DIAGNOSIS: DISEASE L4-5 AND L5-S1. RPTR IS DISABLED, HAS BEEN HOSPITALIZED AND ALSO REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIELKE INSTRUMENTATION WITH PEDICLE SCREW Implant MCV STUART DRUG & SURGICAL SUPPLY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R| S