BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITPC 30 8X30MM CANNULA 1,2MM

    MDR report key: 8514048 · Received April 15, 2019

    Report

    Report Number
    3004549189-2019-00028
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    January 4, 2017
    Report Date
    March 22, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. THESE TWO BATCHES OF SCREWS PRESENT NO MANUFACTURING DEFECT. EVERYTHING CONFORMS TO SPECIFICATIONS. FAILURE TO INSERT THE SCREWDRIVER IN BOTH SCREWS CANNOT BE ATTRIBUTED TO MANUFACTURING CONDITIONS. SCREW DAMAGE COULD HAVE ONLY OCCURRED AFTER PACKAGING, SINCE THE SCREW RECESS IS INSPECTED TWICE AFTER INJECTION. THE SCREWS COULD NOT BE PLACED ON THE SCREWDRIVER BECAUSE THEY HAD SUFFERED SIGNIFICANT OVERALL DEFORMATION, ESP. THE SCREW RECESS. THESE PARTICULAR DEFORMATIONS WERE CAUSED BY EXPOSURE, LASTING SEVERAL MINUTES, TO A TEMPERATURE GREATER THAN THE POLYMER'S GLASS TRANSITION. EXPOSURE TO THE HEAT SOURCE MADE THE MATERIAL MALLEABLE WHICH CAUSED EACH SCREW TO COLLAPSE UNDER ITS OWN WEIGHT OVER ITS FULL LENGTH. THIS INCIDENT MAY HAVE OCCURRED EITHER DURING TRANSPORT OR ON THE STORAGE SITE.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. "WHILE ATTEMPTING TO PLACE THE IMPLANT ON THE SCREWDRIVER, THE FEMALE END OF THE IMPLANT WOULD NOT FIT ON THE SCREWDRIVER. TWO IMPLANTS WERE ATTEMPTED BEFORE USING ANOTHER SIZE." 1ST SCREW : LOT 141446 - MANUFACTURING DATE : MAY 24TH 2014 - EXPIRATION DATE : MAY 24TH 2017; 2ND SCREW : LOT 143836 - MANUFACTURING DATE : NOV. 29TH 2014 - EXPIRATION DATE : NOV. 29TH 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309030 COMPOSITPC 30 8X30MM CANNULA 1,2MM INTERFERENCE SCREW MAI S.B.M. SAS 141446 + 143836

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other