BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SINGLE-INNER SETSCREW

    MDR report key: 3250121 · Received July 26, 2013

    Report

    Report Number
    1526439-2013-22239
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 4, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED SINGLE INNER SETSCREW [PRODUCT CODE: 1797-02-000, LOT NO: APBC52] NOTED THAT THE THREADS WERE COMPLETELY SHEARED OFF. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SINGLE INNER SETSCREW [PRODUCT CODE: 1797-02-000, LOT NO: APBC52] WAS CONDUCTED IDENTIFYING A LOT QUANTITY OF 471 UNITS WAS RELEASED ON FEBRUARY 2ND, 2013 AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND (B)(4) RELATED COMPLAINTS FOR PRODUCT CODE: 1797-02-000. A FURTHER REVIEW OF THE SALES AND COMPLAINT DATA OF A 12 MOTH TO DATE PERIOD FOUND THE OBSERVED (B)(4) TO BE DEEMED ACCEPTABLE WITHIN OUR INTERNAL RISK ASSESSMENT OCCURRENCE RATE OF THE DESIGN FAILURE MODE AND EFFECTS ANALYSIS (DVA-100484-DRAD REVISION C). FURTHERMORE, THERE WERE NO RELATED COMPLAINTS OF SET SCREW STRIPPING FOR THE REPORTED LOT NO: APBC52. A REVIEW WITH PRODUCT DEVELOPMENT WAS CONDUCTED AND NO DEFINITIVE CONCLUSIONS AS TO THE ROOT CAUSE COULD BE DRAWN. HOWEVER, THE DAMAGE IS INDICATIVE OF THE SET SCREW NOT HAVING BEEN PROPERLY ALIGNED WITH THE PEDICLE SCREW DURING SET SCREW ASSEMBLY AND/OR THE APPLICATION OF MEDIAL/LATERAL FORCES DURING FINAL TIGHTENING. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THE RATE OF FAILURE IS IN LINE WITH THE RISK PROFILE ESTABLISHED IN DESIGN CONTROL DOCUMENTATION. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT DURING THE PROCEDURE, THE THREADS OF THE SCREW BECAME STRIPPED AND SEPARATED FROM THE DEVICE. ALL PIECES WERE REMOVED FROM THE SURGICAL SITE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DIFFICULTY DID NOT RESULT IN A SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351346 EXPEDIUM SINGLE-INNER SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE APBC52

    Patients

    Seq Age Sex Outcome Treatment
    1