BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYLINE VARIABLE S-D SCW, 14MM

    MDR report key: 3840978 · Received May 30, 2014

    Report

    Report Number
    1526439-2014-11536
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 4, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PK052552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS INDICATED ON THE INITIAL MEDWATCH REPORT, THE SKYLINE SCREW WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS NO LOT NUMBER IS UNKNOWN. WITHOUT THE LOT NUMBER, A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE COMPLETED. A TWELVE MONTH COMPLAINT TREND ANALYSIS WAS CONDUCTED AND THE DEVICE FAMILY HAS BEEN REVIEWED AS A PART OF POST MARKET SURVEILLANCE ACTIVITIES WITH NO DESIGN ACTIONS REQUIRED AS A RESULT. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AS PART OF POST MARKET SURVEILLANCE ACTIVITIES. THE RETURNED CONCOMITANT DEVICE TORQUE HANDLE WAS TESTED FOR EFFECTIVENESS AND MET SPECIFICATION REQUIREMENTS. AS THE SKYLINE SCREW WAS NOT RETURNED FOR EVALUATION, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE SCREW BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE REOPENED AND THE SCREW MAY THEN BE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED FOR EVALUATION

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT THE IMPLANTED SKYLINE VARIABLE SELF-DRILLING SCREW WAS BACKING OUT FROM A SKYLINE CERVICAL PLATE. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2014. IT WAS REPORTED THAT THE SCREW IS NOT BEING RETURNED FOR EVALUATION. HOWEVER, A CONCOMITANT DEVICE UNIPLATE 2 CAM TIGHTENER TORQUE HANDLE IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318404 SKYLINE VARIABLE S-D SCW, 14MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNIPLATE 2 CAM TIGHTENER TORQUE HANDLE| BENGAL CAGES| VARIABLE ANGLE SELF DRILLING SCREWS| SKYLINE CERVICAL PLATE