BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END CAP, SCN T2 SCN

    MDR report key: 8075190 · Received November 15, 2018

    Report

    Report Number
    0009610622-2018-01397
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    October 19, 2018
    Report Date
    February 15, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540378613
    PMA / PMN Number
    K023267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT END CAP, SCN T2 SCN WAS ALLEGED OF IMPLANT MIGRATION COULD NOT BE CONFIRMED. ALTHOUGH X-RAYS WERE REPEATEDLY REQUESTED BUT NOT PROVIDED UNTIL TIME OF INVESTIGATION CLOSURE AND THUS, THE REPORTED EVENT OF UNINTENDED MOVEMENT OF END CAP AFTER IMPLANTATION COULD NOT BE VERIFIED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE INSPECTION REVEALED THE FOLLOWING: WE RECEIVED AN END CAP, SCN T2 SCN FOR EVALUATION. DETAILED VISUAL INSPECTION REVEALED CLEAR SIGNS OF USAGE. THE WINDINGS SHOW MATERIAL ABRASION [SLIGHT DENTS] AND THE INNER SIDE OF HEXAGON SHOWS SCRATCHES. DUE TO THE NATURE OF THE RETURNED DEVICE, A FUNCTIONAL INSPECTION WAS NOT POSSIBLE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    AT (B)(6) 2018, OPERATION WITH T2SCN WAS DONE. AFTER THE OPERATION, THE END CAP WAS CAME OUT AND THE MOST DISTAL CONDYLE SCREW WAS BACKED OUT. THEREFORE, AT (B)(6) 2018, THE END CAP AND CONDYLE SCREW WAS REMOVED AND NEW SAME DEVICES WERE IMPLANTED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AT (B)(6) 2018, OPERATION WITH T2SCN WAS DONE. AFTER THE OPERATION, THE END CAP WAS CAME OUT AND THE MOST DISTAL CONDYLE SCREW WAS BACKED OUT. THEREFORE, AT (B)(6) 2018, THE END CAP AND CONDYLE SCREW WAS REMOVED AND NEW SAME DEVICES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914562 END CAP, SCN T2 SCN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0973BF 04546540378613

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention