BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOIMPLANT TECHNOLOGIES INC. HIP SYSTEM

    MDR report key: 2228444 · Received March 18, 2009

    Report

    Report Number
    MW5021905
    Event Type
    Injury
    Date Received
    March 18, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 18, 2009
    Manufacturer
    OSTEOIMPLANT TECHNOLOGIES INC./PINNACLE HOLDING
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - ALPHA II STEM - MODULAR NECK OTI FRACTURE SIZE 8X32MM. ENCORE MEDICAL/DJO SURGICAL 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 ENCORE'S ACQUISITION OF THE OTI PRODUCT LINES, OTI -NOT KNOWN AND 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 HAS BEEN FORWARDED TO (B)(6) AT PINNACLE HOLDING INC., (B)(6). NOTE: PRODUCT WAS RETURNED TO ENCORE ON (B)(6) 2009. PRODUCT WILL BE FORWARDED BY ENCORE TO PINNACLE HOLDING INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOIMPLANT TECHNOLOGIES INC. HIP SYSTEM NECK, MODULAR 8 DEG/32MM LPH OSTEOIMPLANT TECHNOLOGIES INC./PINNACLE HOLDING UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability HEAD, PART NUMBER AND LOT NUMBER UNKNOWN