BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA

    MDR report key: 1250463 · Received October 13, 2008

    Report

    Report Number
    1822565-2008-00696
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTO
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PART IS NOT RETURNED FOR ANALYSIS. POTENTIAL LIFE OF INSTRUMENT IS UNK AND THE PT CHARACTERISTICS ARE ALSO UNAVAILABLE. THE ROOT CAUSE CANNOT BE ARRIVED AT WITHOUT THE ABOVE INFO. EVAL: THE PROD STATED IN THE COMPLAINT WAS NOT RETURNED FOR REVIEW. THE DEVICE HISTORY RECORDS INDICATE THAT THE DEVICE WAS MFG AND PACKAGED TO SPEC. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA * HTO ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1