BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10389

    MDR report key: 2988965 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-10389
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    March 3, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    PATIENT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PREOPERATIVE DIAGNOSIS WAS DISC FAILURE OR PROLAPSE, OSTEOPHYTIC SPONDYLOSIS (VERTEBRAL BODY), AND SPONDYLOLISTHESIS, DEGENERATIVE. PATIENT WAS IMPLANTED WITH A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (TPLIF) SPACER AT LEVELS L4 L5 SIZE, WITH PEDICLE SCREWS AT L4 AND L5. PATIENT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR 48 MONTHS. SURGERY DATE WAS (B)(6) 2004, AND POSTOPERATIVELY PATIENT EXPERIENCED TREMENDOUS PAIN TO LEFT LOWER EXTREMITY AND LOW BACK, REQUIRING INCREASED NEURONTIN, ADDED ULTRACET. COMPLAINT #06 OF 12. THIS REPORT IS FOR THE LOCKING CAP AT L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86905 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention