BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICK-X LOCKING CAP

    MDR report key: 2945365 · Received February 1, 2013

    Report

    Report Number
    2520274-2013-10003
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    November 14, 2005
    Report Date
    May 15, 2006
    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

    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 A TPLIF SPACER AT LEVELS L5S1SIZE, WITH PEDICLE SCREWS AT L5 AND S1. PATIENT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR 276 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PATIENT DEVELOPED PSEUDOMENINGOCELE, REQUIRING OBSERVATION. THIS IS 02 OF 06 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44036 CLICK-X LOCKING CAP NONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 PEDICLE SCREWS X 4| CLICK-X LOCKING CAP