BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1742694 · Received June 30, 2010

    Report

    Report Number
    9611820-2010-00009
    Event Type
    Injury
    Date Received
    June 30, 2010
    Report Date
    June 1, 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

    AN ERROR WAS MADE ON THE INITIAL REPORT REGARDING THE DESCRIPTION OF THIS INCIDENT. IT WAS REPORTED THAT THE CONNECTION BETWEEN THE CROWN AND THE ABUTMENT BECAME LOOSE AND SUBSEQUENTLY FRACTURED. THIS STATEMENT IS INCORRECT. FURTHER INVESTIGATION INDICATED THAT THE FRACTURE ACTUALLY OCCURRED BETWEEN THE METAL AND CERAMIC PORTIONS OF THE ABUTMENT. AS STATED IN THE INITIAL REPORT, THE PRODUCT MET SPECIFICATIONS AND THE FRACTURE WAS LIKELY DUE TO THE TECHNIQUE THE CLINICIAN USED TO DRILL THROUGH THE CERAMIC CROWN IN ORDER TO REACH THE SCREW CHANNEL.

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THIS INCIDENT IS THE RESULT OF THE TECHNIQUE THE DOCTOR USED TO DRILL THROUGH THE CERAMIC CROWN IN ORDER TO REACH THE SCREW CHANNEL. THE DRILLING CAUSED THE LOOSENING AND SUBSEQUENT BREAKING OF THE CONNECTION BETWEEN THE CROWN AND THE ABUTMENT. THE DOCTOR DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE CEMENT OR CROWN MATERIAL THAT WAS USED. AN INCOMING GOODS INSPECTION WAS CONDUCTED ON THE RETURNED ABUTMENT AND INDICATED THAT THE PRODUCT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2010 A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS (B)(4) THAT A CROWN BECAME DETACHED FROM A PITT EASY ABUTMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT AN ALARM ON THE HOMECHOICE MACHINE DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE HAD THE HOME PATIENT (HP) PUSH THE SPIKE INTO THE SUPPLY BAG AND TURN. PER THE HP, THE SPIKE HAD NOT PENETRATED THE SEAL OF THE SUPPLY BAG. THE HP RESUMED PRIME. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R