BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL

    MDR report key: 7533545 · Received May 22, 2018

    Report

    Report Number
    8030965-2018-53910
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    January 1, 2017
    Report Date
    May 2, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    DZI
    UDI-DI
    07611819353596
    PMA / PMN Number
    K082649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN; UNKNOWN DATE IN JANUARY 2017; ADDITIONAL PRODUCT 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 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 THE DRILL TIP WAS BROKEN DURING SURGERY IN (B)(6) 2017. THE SURGEON COULD NOT REMOVE THE BROKEN FRAGMENT, SO THAT THE SURGERY WAS COMPLETED WITH THE BROKEN FRAGMENT IN THE PATIENT¿S BONE WITH NO REPORTED DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375530 Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL DRILL, BONE, POWERED DZI OBERDORF SYNTHES PRODUKTIONS GMBH 07611819353596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention