BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR HEIDBRINK DE 13/14

    MDR report key: 2171927 · Received April 13, 2006

    Report

    Report Number
    8010704-2006-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2006
    Date of Event
    February 28, 2006
    Report Date
    February 28, 2006
    Manufacturer
    NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH
    Product Code
    EMJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED TO THE MFR. WHEN QUESTIONED ON THE TELEPHONE ON (B)(6) 2006, THE INITIAL RPTR STATED THAT HE DOES NOT KNOW WHETHER THE INSTRUMENT WAS DISCARDED OR NOT, SINCE HE WORKS AT A MEDICAL CENTER AND IS NOT IN CHARGE OF THESE MATTERS. HE WILL HAVE THIS CHECKED AND HAS PROMISED TO GET BACK TO (B)(4) AS SOON AS MORE INFO IS AVAILABLE. HE ALSO HAS NO IDEA FROM WHICH DISTRIBUTOR OR MFR - OF THE HUNDREDS WHO MARKET THIS TYPE OF PRODUCT-- THE INSTRUMENT WAS PURCHASED NOR WHEN. (B)(4) IS ONE OF MANY DISTRIBUTORS HIS MEDICAL CENTER WORKS WITH AND WAS CHOSEN BY HIM COMPLETELY AT RANDOM SIMPLY TO INQUIRE ABOUT THE PT BEING ABLE TO HAVE AN MRI OR NOT. (B)(4) IN TURN USED TO ACQUIRE THIS TYPE OF INSTRUMENT FROM ANOTHER MFR AND/OR REPACKAGER/RELABELER BEFORE (B)(4). SINCE THE INSTRUMENT HAS NOT BEEN RETURNED, IT WAS IMPOSSIBLE TO DETERMINE THE DATE OF PURCHASE. (B)(4), AS THE CURRENT SUPPLIER, WAS NOTIFIED. ALTHOUGH NO CERTAINTY WHATSOEVER EXISTS THAT THE INSTRUMENT INVOLVED IN THE EVENT ORIGINALLY CAME FROM (B)(4), AFTER RECEIVING INFO ABOUT THE EVENT, (B)(4) PROCEEDED. ALL INSTRUMENTS OF THE TYPE INVOLVED WERE SUBJECTED TO FATIGUE, ROCKWELL AND BREAKAGE TESTS. ON (B)(6) 2006, ALL TESTS WERE COMPLETED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE ELEVATOR TIP BROKE OFF IN THE PT'S BONE DURING A TOOTH EXTRACTION. AN X-RAY SHOWED THAT A SMALL PIECE OF THE BROKEN TIP IS LODGED IN THE PT'S BONE. WHEN QUESTIONED ABOUT THIS ON THE TELEPHONE, THE DOCTOR STATED THAT HE DECIDED NOT TO REMOVE THE BROKEN PIECE SINCE IT IS LOCATED TOO CLOSE TO A NERVE AND HE DOES NOT "WISH TO GO IN THERE." THE DOCTOR'S ONLY CONCERN IS REGARDING THE ADVISABILITY OF SUBJECTING THE PT TO AN MRI. NO DAMAGE OR HARM HAS COME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATOR HEIDBRINK DE 13/14 DENTAL ROOT TIP ELEVATOR EMJ NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention