BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOIMPLANT TECHNOLOGIES INC., ALPHA HIP SYSTEM

    MDR report key: 1543984 · Received October 2, 2009

    Report

    Report Number
    MW5013625
    Event Type
    Injury
    Date Received
    October 2, 2009
    Date of Event
    September 8, 2009
    Report Date
    October 2, 2009
    Manufacturer
    PINNACLE HOLDING INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - REASON UNK AT THIS TIME. CO REC'D 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 FACILITY'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 FACILITY ACQUISITION OF THEIR PRODUCT LINES IN 2005. THE INFO IN THIS REPORT AND ANY ASSOCIATED PARTS WILL BE FORWARDED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOIMPLANT TECHNOLOGIES INC., ALPHA HIP SYSTEM ACETABULAR LINER KWB PINNACLE HOLDING INC. L263

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability