BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI ANTERIOR TENSION BAND PLATE

    MDR report key: 2945303 · Received February 1, 2013

    Report

    Report Number
    3003506883-2013-10004
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    January 13, 2011
    Manufacturer
    SYNTHES (USA) ELMIRA
    Product Code
    KWQ
    PMA / PMN Number
    K022791
    Product Problem
    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

    IT WAS REPORTED THAT A PT PARTICIPATED IN A (B)(6) STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PT WAS IMPLANTED WITH AN ANTERIOR LUMBAR INTERBODY FUSION SPACER AT LEVEL L5-S1 SIZE. PT WAS ALSO IMPLANTED WITH AN ANTERIOR TENSION BAND (ATB) PLATE AT SCREW L5-L (LEFT), SCREW L5-R (RIGHT), SCREW S1-L, AND SCREW S1-R, WITH ATB PLATE 449.074. PT EXPERIENCED PAIN FOR 10 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PT EXPERIENCED RIGHT SACROILIITIS AND MOTOR VEHICLE ACCIDENT, REQUIRING PHYSICAL THERAPY, PAIN MODALITIES, AND PAIN MEDICATION. THIS IS 1 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45213 TI ANTERIOR TENSION BAND PLATE KWQ SYNTHES (USA) ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1