BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEAD STANDARD EXTENDED STEM, 6MM COLLAR, SIZE 2

    MDR report key: 5316829 · Received December 21, 2015

    Report

    Report Number
    0008031020-2015-00564
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    KWI
    PMA / PMN Number
    K102180
    Product Problem
    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. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. (B)(4). DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    IMPLANT BREAKING THROUGH PACKAGING - SBI IS CURRENTLY CONDUCTING A RECOVERY OF PACKAGED PRODUCT ASSOCIATED WITH THE PACKAGING BREACH. THIS ACTIVITY WILL REPACKAGE SBI PRODUCT WITH A (2) YEAR EXPIRATION DATE. CONCURRENTLY A NEW PACKAGE DESIGN IS UNDER VALIDATION.

    Description of Event or Problem · 1

    IMPLANT BREAKING THROUGH PACKAGING - (B)(4) IS CURRENTLY CONDUCTING A RECOVERY OF PACKAGED PRODUCT ASSOCIATED WITH THE PACKAGING BREACH. THIS ACTIVITY WILL REPACKAGE (B)(4) PRODUCT WITH A (2) YEAR EXPIRATION DATE. CONCURRENTLY A NEW PACKAGE DESIGN IS UNDER VALIDATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841968 RHEAD STANDARD EXTENDED STEM, 6MM COLLAR, SIZE 2 ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS KWI STRYKER GMBH 18528

    Patients

    Seq Age Sex Outcome Treatment
    1 Other