BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10381

    MDR report key: 2972415 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-10381
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    September 20, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. 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

    THE PATIENT PARTICIPATED IN A (B)(4) STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PREOPERATIVE DIAGNOSIS WAS OSTEOPHYTIC SPONDYLOSIS (VERTEBRAL BODY). PATIENT WAS ALSO IMPLANTED WITH A FRA SPACER AT LEVEL L5 AND S1 SIZE. PATIENT 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 LEFT SCREW AT S1 (24MM). PATIENT HAS BEEN EXPERIENCING PAIN FOR 18 MONTHS. SURGERY DATE WAS (B)(6) 2006, AND POSTOPERATIVELY PATIENT EXPERIENCED NEW ONSET OF PAIN, REQUIRING ICE AND HEAT ALTERNATING; SOMA WHICH INITIALLY PATIENT TOOK FROM LEFTOVER MEDICINES FROM SURGERY WITHOUT BEING TOLD BY SURGEON TO DO SO. THIS IS REPORT 3 OF 5 FOR SAME EVENT. THIS COMPLAINT IS ON THE LEFT SCREW AT S1 (24MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69605 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1