BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIEZOSURGERY

    MDR report key: 6330142 · Received February 14, 2017

    Report

    Report Number
    3003933619-2017-00001
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    November 15, 2016
    Report Date
    January 23, 2017
    Manufacturer
    MECTRON S.P.A.
    Product Code
    DZI
    UDI-DI
    E322033700140
    PMA / PMN Number
    K091227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK OF INSERT TIP BREAKAGE HAS ALREADY BEEN IDENTIFIED AND IS CLEARLY MENTIONED WITHIN OUR INSTRUCTION OF USE FOR PIEZOSURGERY INSERTS AND WITHIN OUR RISK ANALYSIS. THIS KIND OF BREAKAGE COULD BE CAUSE BY SEVERAL FACTORS. NEVERTHELESS, WE DID NOT RECEIVE ENOUGH INFORMATION TO PROVIDE A FINAL CONCLUSION. THE DENTIST MUST REFER TO RECOMMENDATIONS INCLUDED IN THE USER MANUAL, ABOUT THE SAFETY REQUIREMENTS DURING USE, WHERE IT IS RECOMMENDED TO CHECK IN CASE OF BREAKAGE OF THE INSERT TIP THAT NO FRAGMENTS REMAIN IN THE TREATED PART AND TO EFFICIENTLY ASPIRATE AND REMOVE SUCH PARTS. THE BROKEN INSERT TIP WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND THE INFORMATION PROVIDED WAS NOT SUFFICIENT. DESPITE SEVERAL REMINDERS TO THE DOCTOR, OUR DISTRIBUTOR DID NOT SUCCEED IN CONVINCING THE DENTIST TO REMOVE THE FRAGMENT FROM THE BONE AND PROVIDE INFORMATION ABOUT THE CURRENT HEALTH STATUS OF THE PATIENT. DEVICE NOT RETURNED BY DOCTOR.

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING AN ALVEOLAR RIDGE SPLIT. DOCTOR BROKE THE INSERT TIP IN PATIENT BONE. DOCTOR PLACED DENTAL IMPLANT. DOCTOR TOOK DENTAL X-RAYS AND OBSERVED BROKEN INSERT TIP IN BON IN X-RAY. DOCTOR REMOVED IMPLANT AND ATTEMPTED TO RETRIEVE BROKEN INSERT TIP. DOCTOR WAS UNABLE TO RETRIEVE INSERT TIP. DOCTOR REPLACED DENTAL IMPLANT. DOCTOR CONTACTED PIEZOSURGERY INCORPORATED FOR ADVICE ON HOW TO PROCEED. DOCTOR WAS ADVISED TO REMOVE THE BROKEN INSERT TIP. DOCTOR STATED THAT BECAUSE THE INSERT TIP IS COMPOSED OF SIMILAR MATERIAL TO THAT OF SURGICAL STEEL AND TITANIUM IN WIRES AND OTHER DENTAL HARDWARE THAT IS MADE TO REMAIN IN THE BODY, THAT HE WOULD LEAVE THE INSERT TIP IN THE BONE OF THE PATIENT AND MONITOR THE PATIENT. PIEZOSURGERY INCORPORATED INDICATED THAT THE DEVICE MANUAL EXPLICITLY STATES TO REMOVE INSERT FRAGMENTS. DOCTOR STATED THAT TO REMOVE THE TIP INSERT, HE WOULD HAVE TO ABORT HIS PROCEDURE. PIEZOSURGERY INCORPORATED ADVISED THE DOCTOR TO ABORT THE PROCEDURE. PIEZOSURGERY INCORPORATED STATED THAT IT WOULD REPORT THE EVENT AND SENT THE DOCTOR RMA PAPERWORK AND ADVERSE EVENT FORMS TO FILL OUT. DOCTOR FAILED TO RETURN EMAIL, PHONE CALLS, AND CERTIFIED MAIL CORRESPONDENCE, AS WELL AS ANY PATIENT INFORMATION OR ASSOCIATED PAPERWORK. THEREFORE, NO PATIENT INFORMATION HAS BEEN LISTED IN THIS FORM. THE PIEZOSURGERY 3 DEVICE WAS USED WITH THE OT7S-4 INSERT TIP (INSERT TIP WAS PURCHASED IN 2011).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111101 PIEZOSURGERY OT7S-4, INSERT TO PIEZOSURGERY DZI MECTRON S.P.A. OTS7-4 11/00153 E322033700140

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R