BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1935805 · Received December 22, 2010

    Report

    Report Number
    9611820-2010-00023
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABUTMENT WAS RETURNED TO (B)(4) AND EVALUATED. A VISUAL INSPECTION INDICATED THAT THE ABUTMENT MEETS PRODUCT SPECIFICATIONS AND THAT THE HEX FRACTURE WAS NOT THE RESULT OF A DESIGN FLAW OR A MANUFACTURING ERROR, BUT TO OVERLOADING AFTER SCREW LOOSENING. THIS IS NOT A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON (B)(6), 2010 A DOCTOR REPORTED TO (B)(4) THAT A PITT EASY ABUTMENT FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PITT EASY ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA SYBRON IMPLANT SOLUTIONS GMBH 949201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R