BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED ? 5X60MM

    MDR report key: 1199336 · Received October 15, 2008

    Report

    Report Number
    9610622-2008-00191
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 23, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 9610622-2008-00192, 9610622-2008-00193, AND 9610622-2008-00194. ADD'L 510(K) #: K424350/K614220.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE SALES REP THAT THE PT UNDERWENT A REVISION ON THE (B)(6) 2008 TO REMOVE A T2 TIBIAL NAIL AS TWO OF THE PROXIMAL LOCKING SCREWS HAD BROKEN. IT IS FURTHER REPORTED THAT THE ORIGINAL IMPLANTATION TOOK PLACE ON THE (B)(6) 2008 WHERE THE NAIL WAS IMPLANTED WITH 2 LOCKING SCREWS PROXIMALLY AND 3 SCREWS DISTALLY. IT IS FURTHER REPORTED THAT 4 WEEKS POST OPERATIVELY, THE PT PRESENTED WITH PAIN AT THE FRACTURE SITE AND THE KNEE. IT IS FURTHER REPORTED THAT THE (B)(6) FEMALE PT HAD NOT SUFFERED ANY FALL OR TRAUMA PRIOR TO THE REVISION AND WAS OF SLIGHT BUILD. IT IS FURTHER REPORTED THAT DURING THE REVISION, THE SURGEON REMOVED THE NAIL BUT COULD NOT REMOVE ALL PARTS OF THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED ? 5X60MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention