BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPORE ABUTMENT

    MDR report key: 1982783 · Received February 9, 2011

    Report

    Report Number
    2016150-2011-00039
    Event Type
    Injury
    Date Received
    February 9, 2011
    Report Date
    January 24, 2011
    Manufacturer
    SYBRON IMPLANT SOLUTIONS
    Product Code
    NHA
    PMA / PMN Number
    K952434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR THE PATIENT'S CURRENT HEALTH STATUS, NOR DID HE PROVIDE A CAUSE FOR THE FRACTURE. A PORTION OF THE RETURNED SCREW WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE SCREW FRACTURED AT THE SECOND THREAD. THIS OBSERVATION LED TO THE CONCLUSION THAT THE FRACTURE MAY HAVE BEEN DUE TO OVER-TORQUING AND THEREFORE USER TECHNIQUE. THE REMAINING PORTION OF THE FRACTURED SCREW COULD NOT BE EVALUATED BECAUSE IT COULD NOT BE RETRIEVED FROM THE HOUSING OF THE ABUTMENT. NO FURTHER INVESTIGATION IS POSSIBLE, AS NO PRODUCT LOT NUMBER WAS PROVIDED AND A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS THAT AN ENDOPORE ABUTMENT SCREW FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPORE ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA SYBRON IMPLANT SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other