BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L26 TAN

    MDR report key: 3030079 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01300
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PRODUCT WAS RETURNED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    EVENT DATE REPORTED INCORRECTLY IN INITIAL MW; DATE IS UNKNOWN. (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: ON (B)(6) 2013, THE PROCEDURE DOCTOR SELECTED FOR A FRACTURE OF THE PROXIMAL HUMERUS WAS OPEN REDUCTION AND INTERNAL FIXATION BY USE OF PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM. ON (B)(6) 2013, HE STARTED SLOWLY A COURSE OF PHYSIOTHERAPY, BENDING ABOUT 90 DEGREES. ON (B)(6), THE DISTAL SCREW WAS MOBILIZED AND THE FEMORAL HEAD WAS INVERTED. A REPORT AFTER THE FACT STATED: THE FRACTURE PART WAS MOBILIZED A LITTLE, AS FAR AS THE DOCTOR LOOKED AT THE X-RAY IMAGES CLOSELY. AND IT WAS RECOGNIZED THAT THE SCREW WAS LOOSENED. ON (B)(6), THE SURGEON CHANGED THIS IMPLANT TO ARTIFICIAL FEMORAL HEAD FOR THE PATIENT. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134686 LOCKSCR Ø3.5 SELF-TAP L26 TAN KTT SYNTHES GMBH 7827946

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention