BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø3.5 L28 TI

    MDR report key: 3030077 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01301
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K131186
    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. (B)(4). 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. ADDITIONAL INFORMATION: HWC. (B)(4). 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 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133947 CORTSCR Ø3.5 L28 TI HRS SYNTHES GMBH 3771040

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention