BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITPC 60 9X30MM

    MDR report key: 8514053 · Received April 15, 2019

    Report

    Report Number
    3004549189-2019-00029
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    December 12, 2016
    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. THIS BATCH OF SCREWS PRESENTS NO MANUFACTURING DEFECT. EVERYTHING CONFORMS TO SPECIFICATIONS. IN THE ABSENCE OF EXPERTISE OF THE SCREW (NO RETURN) AND WITHOUT ADDITIONAL INFORMATION ON THE CIRCUMSTANCES OF THE BREAKAGE, THE ORIGIN OF THE INCIDENT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. "DURING AN INITIAL ACL PROCEDURE, PRECISELY IN TIBIAL FIXATION WITH THE COMPOSITCP SCREW, THE SURGEON FOUND THE SCREW BROKEN AT THE TIP WITHOUT BLENDING OR FORCING IT. THERE WERE NO COMPLICATIONS OR DELAY REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309034 COMPOSITPC 60 9X30MM INTERFERENCE SCREW MAI S.B.M. SAS 162529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other