BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1648440 · Received April 1, 2010

    Report

    Report Number
    9611820-2010-00004
    Event Type
    Injury
    Date Received
    April 1, 2010
    Report Date
    March 2, 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

    A DOCTOR REPORTED THAT ONE PITT-EASY ABUTMENT SCREW FRACTURED WHILE HE WAS RATCHETING IT INTO PLACE. THE DOCTOR STATED THAT THE RACHET HE USED WAS NOT WORKING PROPERLY AND HAD NOT BEEN PROPERLY CALIBRATED. HE ALSO STATED THAT THE RACHET WAS NOT MANUFACTURED BY SYBRON IMPLANT SOLUTIONS (B) (4). THE ABUTMENT WILL BE REPLACED USING THE PROPER RACHET. NO PATIENT INFORMATION WAS PROVIDED AND THE PRODUCT HAS NOT YET BEEN RETURNED TO SYBRON IMPLANT SOLUTIONS (B) (4) FOR EVALUATION. WHEN AN EVALUATION OF THE FRACTURED ABUTMENT HAS BEEN CONDUCTED A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B) (6) 2010 A DOCTOR REPORTED THAT ONE PITT-EASY ABUTMENT SCREW FRACTURED WHILE HE WAS RATCHETING IT INTO PLACE.

    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