BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI ANTERIOR TENSION BAND PLATEONE LEVEL SACRAL/41MM

    MDR report key: 2875327 · Received December 17, 2012

    Report

    Report Number
    2520274-2012-03997
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    March 1, 2007
    Report Date
    January 9, 2009
    Manufacturer
    SYNTHES
    Product Code
    KWQ
    PMA / PMN Number
    K022791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    EU COMPLAINT HANDLING UNIT REPORTED A PATIENT PARTICIPATED IN A (B)(4) STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PREOPERATIVE DIAGNOSIS WAS DISC FAILURE OR PROLAPSE. THE PATIENT WAS IMPLANTED WITH AN FRA SPACER AT LEVEL L5 S1 SIZE. THE PATIENT WAS ALSO IMPLANTED WITH AN ATB PLATE AT SCREW L5 L, SCREW L5 R, SCREW S1 L, AND SCREW S1 R, WITH ATB PLATE (B)(4). THE PATIENT HAD BEEN EXPERIENCING PAIN FOR 180 MONTHS. THE SURGERY DATE WAS (B)(6) 2007. POSTOPERATIVELY, THE PATIENT EXPERIENCED MIGRATION OF THE RIGHT S1 SCREW, REQUIRING SURGICAL REMOVAL OF THE RIGHT S1 SCREW ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI ANTERIOR TENSION BAND PLATEONE LEVEL SACRAL/41MM TI ANTERIOR TENSION BAND KWQ SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention