BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 13MM

    MDR report key: 6214159 · Received December 29, 2016

    Report

    Report Number
    0001038806-2016-00370
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 6, 2016
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK130949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD NOT BE VERIFIED AS X-RAYS WERE NOT PROVIDED BY THE DENTIST. RETURNED IMPLANT WAS VISUALLY INSPECTED. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT IDENTIFY ANY NON-CONFORMANCES. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD CAUSE OR CONTRIBUTE TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT THE PATIENT DEVELOPED MYCOBACTERIUM INFECTION. IT COULD BE FROM SINUS OR LUNGS. INFECTIOUS DISEASE DOCTOR REQUESTED TO REMOVE IMPLANT. SINUS DEBRIDEMENT PROCEDURE WAS DONE ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863756 OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 13MM DENTAL IMPLANT DZE BIOMET 3I 2015112178

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention