BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HM SYSTEM (NARROW REDGE)

    MDR report key: 3062882 · Received April 12, 2013

    Report

    Report Number
    3007135442-2013-00017
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    PMA / PMN Number
    K080594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    HIOSSEN INC WAS REPORTED BY THE DOCTOR THAT THE PT THE PT HAS FAIR BONE QUALITY. BUT THE X-RAYS PROVIDED SHOWED THAT THE PT HAS POOR BONE QUALITY. ALSO INFECTION WAS INVOLVED IN THE CASE. BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATION. FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN INHERENT RISK OF DENTAL IMPLANTS. THIS IS WELL DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEMS. IN ADDITION, FAILURE TO OSSEOINTEGRATE IS INCLUDED IN THE IFU AS A KNOWN COMPLICATION WITH VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR.

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2012 IN SITE AREA #24. AN INFECTION WAS INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157824 HM SYSTEM (NARROW REDGE) DENTAL IMPLANT DZE HIOSSEN INC. HMN2515R03 H1G10F104

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention