BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN RHEAD

    MDR report key: 7861992 · Received September 10, 2018

    Report

    Report Number
    0008031020-2018-00601
    Event Type
    Death
    Date Received
    September 10, 2018
    Date of Event
    January 1, 2002
    Report Date
    September 10, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    KWI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT STRYKER RHEAD WAS ALLEGED THAT THE PATIENT DIED COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. NO PRODUCT IDENTIFICATION IS POSSIBLE AND NO ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. BASED ON THE INVESTIGATION, NO RELATION COULD BE ESTABLISHED BETWEEN THE PRODUCT AND THE RESULTING ADVERSE CONSEQUENCE. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6). THE TITLE OF THIS REPORT IS ¿RHEAD REPORTED IN THE (B)(6) WHICH IS ASSOCIATED WITH THE RHEAD SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2002 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 3 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DEATH AFTER THE PRIMARY OPERATION, THE EXACT DATE OF THE DEATH WILL NOT BE DISCLOSED. ONE OUT OF 2 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703368 UNKNOWN RHEAD IMPLANT KWI STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death