BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE SYSTEM ROD, TITANIUM ALLOY

    MDR report key: 241094 · Received September 16, 1999

    Report

    Report Number
    2916714-1999-00018
    Event Type
    Injury
    Date Received
    September 16, 1999
    Date of Event
    August 16, 1999
    Report Date
    September 16, 1999
    Manufacturer
    AESCULAP - JBS S.A.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL SURGERY DATE WAS 5/5/1997. PT'S DIAGNOSIS AT THE TIME WAS GRADE I SPONDYLOLISTHESIS L5-S1 AND UNDERWENT BILATERAL LAMINECTOMY OF L5 WITH FORAMINOTOMIES FOLLOWED BY POSTERIOR INSTRUMENTATION AND FUSION L5-S1 UTILIZING LEFT ILIAC CREST BONE GRAFT. PT INITIALLY DID WELL, HOWEVER, LATER DEVELOPED RECURRENCE OF BACK PAIN AND TINGLING DOWN THE RIGHT LEG. INITIAL X-RAYS REVEALED A MILD LOOSENING AROUND THE S1 SCREWS AND ONE ROD APPEARED TO BE BROKEN. TOMOGRAMS WERE COMPLETED ON 6/2/99 AND CONFIRMED PT HAD BROKEN ROD ON THE RIGHT SIDE, INCOMPLETE FUSION BILATERALLY, AND PERSISTENT SPONDYLOLISTHESIS. ON 8/16/99 PT WAS TAKEN BACK TO SURGERY FOR ANTERIOR/POSTERIOR FUSION. HE HAD ANTERIOR DISCECTOMY AT L5/S1 WITH ANTERIOR INTERBODY FUSION UTILIZING A FEMORAL RING ALLOGRAFT. UNDER SAME ANESTHETIC PT THEN HAD POSTERIOR EXPLORATION AND FUSION WITH REMOVAL OF AESCULAP PEDICLE SCREW INSTRUMENTATION. REPEAT BILATERAL INTERTRANSVERSE FUSION WITH REPEAT INSTRUMENTATION UTILIZING MOSS-MIAMI PEDICLE SCREW SYSTEM WAS THEN PERFORMED WITH HARVESTING OF THE RIGHT ILIAC CREST BONE. PT REPORTED TO BE "CLINICALLY DOING WELL" WITHOUT A SOLID FUSION YET AS IT HAS ONLY BEEN ABOUT 3 MONTHS FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE SYSTEM ROD, TITANIUM ALLOY Implant SPINAL IMPLANT FIXATION DEVICE KWP AESCULAP - JBS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other