BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 3065693 · Received April 18, 2013

    Report

    Report Number
    1030489-2013-01099
    Event Type
    Injury
    Date Received
    April 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    K041556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART# 2961032, LOT# KS06 AND PART# 2961232, LOT# KU47. (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH 'SYMPTOMATIC LUMBAR DEGENERATIVE DISK DISEASE WITH RIGHT GREATER THAN LEFT-SIDED RADICULAR PAIN. HIS PROBLEMS DATE BACK TO 2004 WITH REGARD TO HIS SYNDROME OF BACK AND LOWER EXTREMITY PAIN. HE HAD GONE THROUGH A NUMBER OF CONSERVATIVE THERAPIES AND DID NOT DO WELL WITH SUCH. HE WAS ALSO A CIGARETTE SMOKER AND WAS CONSIDERED INITIALLY TO BE A RATHER POOR SURGICAL CANDIDATE. THE PATIENT WAS TOLD TO EITHER CLEAN UP HIS ACT AND QUIT SMOKING AND RECEIVE PSYCHOLOGICAL COUNSELING FOR HIS DEPRESSION, OR HE WOULD NOT BE CONSIDERED FOR SURGERY.' THE PATIENT UNDERWENT A 360 FUSION L5-S1 AND A POSTERIOR LATERAL ARTHRODESIS L4-5. POSTERIOR INSTRUMENTATION, INTERBODY DEVICES AND RHBMP-2/ACS WERE USED. 'FOLLOWING HIS SURGERY, THE PATIENT HAD A FAIRLY UNEVENTFUL POSTOPERATIVE COURSE AND REMAINED IN THE HOSPITAL FOR 4 DAYS.' PATIENT DISCHARGED ON POD 4. AT 63 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO MIGRATION OF THE INTERBODY DEVICE. THE SURGERY CONSISTED OF REPLACING THE INTERBODY SPACER, AND ADDING POSTERIOR HARDWARE AND RHBMP-2/ACS. PATIENT WAS DISCHARGED ON POD 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168235 VERTE-STACK SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention