BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 5331630 · Received December 29, 2015

    Report

    Report Number
    0008031020-2015-00751
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    February 13, 2014
    Report Date
    February 17, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(6) 2014.  STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. THE CATALOG NUMBER IS UNKNOWN AT THIS TIME AND THE DEVICE WILL NOT BE RETURNED.  IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    REVISION DUE TO HETEROTOPIC BONE, DOWNSIZED POLY FROM 7MM TO 6MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856097 UNKNOWN_SELZACH_PRODUCT IMPLANT HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention