BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HSB

    MDR report key: 2948036 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-10086
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    March 16, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    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 (B)(4) 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

    IT WAS REPORTED THAT A PATIENT PARTICIPATED IN A (B)(4) STUDY OF TREATMENT FOR 1 OR 2 LEVEL GENERATIVE DISC DISEASE BETWEEN L2 AND S1. PATIENT WAS IMPLANTED WITH A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (TPLIF) SPACER AT LEVELS L5S1SIZE WITH PEDICLE SCREWS AT L5 AND S1. PATIENT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. THE PATIENT EXPERIENCED PAIN FOR 60 MONTHS. SURGERY DATE WAS (B)(6) 2005 AND POSTOPERATIVELY PATIENT EXPERIENCED DURAL TEAR, REQUIRING REPAIR OF DURAL TEAR. THIS IS 15 OF 15 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48063 HSB HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention