BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HWC

    MDR report key: 2948069 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-10040
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 14, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    UNK
    Adverse Event
    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 THE 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 PATIENT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PATIENT WAS IMPLANTED WITH AN ANTERIOR LUMBAR INTERBODY FUSION SPACER AT LEVEL L5_S1SIZE. PATIENT WAS ALSO IMPLANTED WITH AN ANTERIOR TENSION BAND (ATB) PLATE AT SCREW_L4_L, SCREW_L4_R, SCREW_L5_L, SCREW_L5_R, SCREW_S1_L, WITH ATB PLATE. THE PATIENT EXPERIENCED PAIN FOR 14 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PATIENT EXPERIENCED VASCULAR INJURY, REQUIRING REPAIRED VASCULAR TEAR DURING SURGERY. THIS IS 7 OF 7 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47969 HWC HWC SYNTHES (USA) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention