BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/32MM-STERILE

    MDR report key: 2925618 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00225
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K110592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT FELL DOWN STAIRS AND WAS TREATED WITH A PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. PATIENT COMPLAINED OF POSTOP PAIN AND UPON EXAMINATION, A BROKEN PLATE WAS FOUND. ON (B)(6) 2012, THE BROKEN PLATE WAS REMOVED AND A REVISION ORIF OF THE DISTAL FEMUR WAS PERFORMED WITH ANOTHER PLATE/SCREW FIXATION. THE PLATE HAD BROKEN AT THE RIGHT COMBI HOLE ALONG WITH ONE OF THE 3 DYNAMIC LOCKING SCREWS THAT ALSO BROKE. THE PLATE WAS REPLACED WITH A ZIMMER NCB DISTAL FEMUR PLATE. THIS IS # 2 OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29577 5.0MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/32MM-STERILE 5.0MM COCR DYNAMIC LOCKING SCREW HRS SYNTHES GMBH 7816040

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR PLATE