BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10372

    MDR report key: 2972388 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-10372
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    October 13, 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

    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, 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 ON LEFT, SCREW L5 ON RIGHT, SCREW S1 ON LEFT, AND SCREW S1 ON RIGHT, WITH ATB PLATE 449.073. PT HAD BEEN EXPERIENCING PAIN FOR 300 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PATIENT EXPERIENCED RIGHT SACROILIITIS, REQUIRING PHYSICAL THERAPY AND PAIN MEDICATIONS. THIS REPORT IS 4 OF 5 FOR THE SAME EVENT. THIS COMPLAINT IS ON THE RIGHT SCREW AT L5 (28MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69601 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1