BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER MIS SINGLE INNER SETSCW

    MDR report key: 3844759 · Received June 3, 2014

    Report

    Report Number
    1526439-2014-11546
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK041801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    VISUAL EXAMINATION OF THE VIPER MIS SINGLE INNER SETSCREW REVEALED NO IMMEDIATE APPARENT DAMAGE TO THE THREADS OF THE SCREW, NOR WAS THERE ANY DAMAGE TO THE TEETH ON THE SCREW BODY¿S INNER DIAMETER. NO DAMAGE WAS SEEN THAT WOULD AFFECT THE PART¿S ABILITY TO FUNCTION. SOME CORROSION IS PRESENT ON THE UNDERSIDE OF THE SET SCREW. THE BASE OF THE SCREW, HOWEVER, DID NOT FEATURE THE WITNESS MARKS THAT ARE FOUND ON SET SCREWS THAT HAVE UNDERGONE THEIR FINAL TIGHTENING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD CONTRIBUTE TO THE PROBLEM REPORTED BY THE CUSTOMER. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE MIS SINGLE INNER SET SCREW WAS CONDUCTED ON THE SPECIFIC PRODUCT CODE FROM THIS COMPLAINT AS NO PRODUCT FAMILY EXISTS FOR THIS PART. THIS ANALYSIS FOUND NO EMERGING TRENDS. THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED FROM THE SAMPLE AND INFORMATION PROVIDED. HOWEVER, A POTENTIAL ROOT CAUSE OF THE MIS SINGLE INNER SET SCREW BECOMING LOOSE POST-OPERATIVELY IS THAT IT DID NOT RECEIVE A FINAL TIGHTENING, ALLOWING THE SET SCREW TO BECOME LOOSE OVER TIME. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THE DEVICE AND NO SYSTEMIC TREND HAS BEEN OBSERVED. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE INITIAL PROCEDURE WAS DONE ON (B)(4) 2013. POS-OPERATIVE X-RAY SHOWED ONE OF THE INNIE SET SCREWS WAS OUT. ON THE LATERAL X-RAY, IT SHOWED THAT THE CONCORDE BULLETED CAGE WAS OUT. THEREFORE, THE SURGEON DECIDED TO SCHEDULE A REVISION SURGERY. THE SURGEON HAD REMOVED THE INNIE SCREW AND THE PEDICLE SCREW TO WHICH IT WAS ASSEMBLED AND REPLACED WITH A BIGGER SIZE SCREW (75MM) AND SET SCREW. THE SURGEON ALSO REMOVED THE CONCORDE BULLET CAGE AND REPLACED WITH A TALLER HEIGHT AND SHORTER LENGTH CAGE. THE CAGE WAS DISCARDED. THE AFFILIATE REPORTS THE PATIENT IS DOING FINE NOW. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE SET SCREW AND CONCORDE BULLET CAGE DEVICES THAT HAD BACKED OUT. 1526439-2014-11546; 1526439-2014-11547.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325110 VIPER MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE APJCNR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VIPER PEDICLE SCREW