BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROCA Ø1.5 C/TRAV C13/6 2AREST-CORT

    MDR report key: 7638674 · Received June 26, 2018

    Report

    Report Number
    8030965-2018-54644
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 1, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    DZI
    UDI-DI
    10887587013619
    PMA / PMN Number
    K082649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. ADDITIONAL CLASSIFICATION CODE: DZJ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURE DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE TIPS OF TWO (2) MATRIXMANDIBLE DRILL BITS BROKE WHILE DRILLING THE HOLE. THE TIPS COULD NOT BE RECOVERED AND WERE LEFT INSIDE THE PATIENT¿S BONE. THERE WAS NO PATIENT CONSEQUENCE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481843 BROCA Ø1.5 C/TRAV C13/6 2AREST-CORT DRILL, BONE, POWERED DZI OBERDORF SYNTHES PRODUKTIONS GMBH 10887587013619

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention