BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10366

    MDR report key: 2972392 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-10366
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    May 24, 2005
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    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 INFO RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNK 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

    PT 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, AND OSTEOPHYTIC SPONDYLOSIS (VERTEBRAL BODY). PT WAS IMPLANTED WITH AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPACER AT LEVEL L5_S1 SIZE. PT WAS ALSO IMPLANTED WITH AN ANTERIOR TENSION BAND (ATB) PLATE AT SCREW_L5_L, SCREW_L5_R, SCREW_S1_L, AND SCREW_S1_R, WITH ATB PLATE 449.072. SURGERY DATE WAS (B)(6) 2005, AND POST-OPERATIVELY PT EXPERIENCED POST-OP ILEUS; BLOOD LOSS ANEMIA, AND RIGHT SACROILITIS, REQUIRING OBSERVATION; LIQUID DIET, AND DIAGNOSTIC/THERAPEUTIC INJECTION (R) SI JOINT. THIS IS REPORT 3 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69518 HWC SYNTHES (USA) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1