BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTI HIP SYSTEM, ALFA II

    MDR report key: 2114539 · Received May 14, 2009

    Report

    Report Number
    MW5020844
    Event Type
    Injury
    Date Received
    May 14, 2009
    Date of Event
    April 24, 2009
    Report Date
    May 14, 2009
    Manufacturer
    OSTEOIMPLANT TECHNOLOGIES, INC. -OTI- NOW KNOWN AS PINNACLE HOLDING INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PT COULD NOT WALK. ENCORE RECEIVED A COMPLAINT ABOUT A REPORTABLE EVENT. IT WAS DETERMINED THAT THE MFR OF THE DEVICE IN QUESTION WAS OSTEOIMPLANT TECHNOLOGIES, INC. -OTI-. AS PART OF ENCORE'S ACQUISITION OF THE OTI PRODUCT LINES, OTI -NOW KNOWN AS PINNACLE HOLDING INC.- AGREED TO ASSUME ALL REGULATORY RESPONSIBILITIES FOR PRODUCT IMPLANTED PRIOR TO ENCORE'S ACQUISITION OF THEIR PRODUCT LINES ON (B)(6) 2005. THE INFO IN THIS REPORT AND ANY ASSOCIATED PARTS HAVE BEEN FORWARDED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTI HIP SYSTEM, ALFA II MODULAR STEM LZO OSTEOIMPLANT TECHNOLOGIES, INC. -OTI- NOW KNOWN AS PINNACLE HOLDING INC. P157
    2 OTI HIP SYSTEM, ALFA II HIP SYSTEM LZO OSTEOIMPLANT TECHNOLOGIES, INC. -OTI- NOW KNOWN AS PINNACLE HOLDING INC. UNK
    3 OTI HIP SYSTEM, ALFA II HIP SYSTEM LZO OSTEOIMPLANT TECHNOLOGIES, INC. -OTI- NOW KNOWN AS PINNACLE HOLDING INC. S346
    4 OTI HIP SYSTEM, ALFA II HIP SYSTEM LZO OSTEOIMPLANT TECHNOLOGIES, INC. -OTI- NOW KNOWN AS PINNACLE HOLDING INC. S016

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability