BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

    MDR report key: 5081829 · Received September 16, 2015

    Report

    Report Number
    3004485144-2015-00052
    Event Type
    Injury
    Date Received
    September 16, 2015
    Report Date
    August 18, 2015
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    LOE
    PMA / PMN Number
    PP850035
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED UNDERGOING A PROCEDURE IN (B)(6) 2008 TO REPAIR A RUPTURED DISK AND AN IMPLANTABLE BONE STIMULATOR WAS UTILIZED FOLLOWING THE PROCEDURE. SUBSEQUENTLY, PATIENT REPORTS ALLEGATIONS OF PAIN AND A LUMP IN THE LOCATION OF THE IMPLANTED BONE STIMULATOR. PATIENT FURTHER ALLEGES THE STIMULATOR WAS REMOVED IN (B)(6) 2010, BUT ALLEGES THAT A PORTION OF THE STIMULATOR REMAINS IMPLANTED BASED ON ALLEGED MRI EVIDENCE. PATIENT FURTHER ALLEGES THAT SCREWS, RODS AND PLATES FROM AN UNKNOWN MANUFACTURER REMAIN IMPLANTED. PATIENT ALLEGES DAMAGE TO ORGANS AND TISSUE FOR WHICH PATIENT IS ALLEGEDLY BEING TREATED BY A PAIN MANAGEMENT PHYSICIAN. THIS REPORT IS BASED ON PATIENT'S ALLEGATIONS THE ABOVE ALLEGATIONS HAVE NOT BEEN VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614339 SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR IMPLANTABLE SPINAL FUSION STIMULATOR LOE BIOMET SPINE - BROOMFIELD N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S