BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-OSS DENTAL IMPLANT

    MDR report key: 117003 · Received August 26, 1997

    Report

    Report Number
    2027763-1997-01008
    Event Type
    Malfunction
    Date Received
    August 26, 1997
    Date of Event
    May 22, 1997
    Report Date
    August 26, 1997
    Manufacturer
    STERI-OSS, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECEIVED REPORT OF A FAILURE. NO FURTHER INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-OSS DENTAL IMPLANT Implant ENDOSSEOUS DENTAL IMPLANT DZE STERI-OSS, INC. 2914HL 971349

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention