BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS

    MDR report key: 3121498 · Received May 21, 2013

    Report

    Report Number
    2520274-2013-02783
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODES: DZI, ERL, HBE. THE LOT # WAS REPORTED AS 1102; HOWEVER, THE PART AND LOT NUMBER COMBINATION IS CANNOT BE CONFIRMED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS NOT POSSIBLE AS THE PART/LOT NUMBER COMBINATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO: DOES NOT MEET THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE MDR REPORT ABILITY STATUS UPDATED TO: DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT: #2520274-2013-02783. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DURING A DENTAL IMPLANT PROCEDURE ON (B)(6) 2013, REPORTEDLY TWO SEPARATE E-PEN ATTACHMENTS (DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS) DID NOT FUNCTION. IT WAS REPORTED A THIRD ATTACHMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. NO HARM TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224530 DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS HWE SYNTHES USA 1102

    Patients

    Seq Age Sex Outcome Treatment
    1