BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-OSS DENTAL IMPLANT

    MDR report key: 114226 · Received August 14, 1997

    Report

    Report Number
    2027763-1997-00850
    Event Type
    Malfunction
    Date Received
    August 14, 1997
    Date of Event
    June 11, 1997
    Report Date
    August 13, 1997
    Manufacturer
    STERI-OSS INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REC'D 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. 5514HL 966581

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention