BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON® TO 4 DEG LORDOTIC, IMPLANT, 22X10MM, PLIF

    MDR report key: 5807122 · Received July 19, 2016

    Report

    Report Number
    3006340236-2016-00005
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 19, 2016
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    MAX
    PMA / PMN Number
    K102067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR BOTH OF THE IMPLANTS THAT WERE IMPLANTED WERE REVIEWED. THE REVIEW REVEALED THERE WERE NO ANOMALIES OR NON-CONFORMANCES GENERATED DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE ENDOSKELETON® TO IFU WAS REVIEWED. THE IFU STATES "SAFETY AND EFFECTIVENESS HAS NOT BEEN ESTABLISHED IN PATIENTS WITH THE FOLLOWING CONDITIONS: MORBID OBESITY; SYMPTOMATIC CARDIAC DISEASE; PREGNANCY; SIGNS OF LOCAL INFLAMMATION; FEVER OR LEUKOCYTOSIS; METAL SENSITIVITY/ALLERGY TO THE IMPLANTS MATERIALS[?]". SINCE THE PATIENT HAS AN UPPER (B)(6), THE DEVICE WAS USED AGAINST THE PRECAUTION CONTAINED WITH THE IFU IN REGARDS TO THE IMPLANTS EFFECTIVENESS.D EVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A CASE WAS COMPLETED ON 05/24/2016 TO IMPLANT TWO ENDOSKELETON® TO 4 DEG LORDOTIC, IMPLANT, 22 X 10MM, PLIF (P/N 3114-2612). THE LOT NUMBER OF THESE IMPLANT ARE A141109 AND A140515. THESE IMPLANTS WERE INSTALLED AT LEVEL L4-L5 AND L5-S1. A REVISION SURGERY DUE TO CONTINUED NERVE PAIN FROM THE IMPLANT BACKING OUT WAS REQUIRED. THE IMPLANT CAGE BACKED OUT OF THE L5-S1 LEVEL. L4-L5 HAS NOT BACKED OUT. A UNILATERAL PROCEDURE AT L5-S1 INCIDENT CITE. THE EXISTING CAGE WAS REMOVED AND A NEW CAGE WAS IMPLANTED. THE EXPLANTED CAGE WAS DESTROYED BY THE HOSPITAL AND THE LOT NUMBER WAS NOT DOCUMENTED. THEREFORE, IT CANNOT BE DETERMINED WHICH LOT WAS EXPLANTED. THE ORIGINAL CASE WAS PERFORMED AT (B)(6) AND THE REVISION CASE WAS PERFORMED AT (B)(6). THE PATIENT WAS A FEMALE WITH AN UPPER (B)(6). THE PATIENT DENIES FALLING. PATIENT DID NOT HAVE PRIOR FUSIONS AT THE LEVELS THAT WERE BEING TREATED. PATIENT WAS SUPPLIED WITH POST-OPERATIVE INSTRUCTIONS. PATIENT WENT HOME WITHIN 48 HOURS AND ISSUES RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461029 ENDOSKELETON® TO 4 DEG LORDOTIC, IMPLANT, 22X10MM, PLIF SPINAL IMPLANT MAX TITAN SPINE, LLC A141109/A140515

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention