BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMF SYSTEM 30MM DRIVE SCREW W/ 65MM FLEX TUBE

    MDR report key: 7490789 · Received May 7, 2018

    Report

    Report Number
    0001032347-2018-00249
    Event Type
    Injury
    Date Received
    May 7, 2018
    Date of Event
    April 7, 2018
    Report Date
    September 20, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK992952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: MQN. LOT NUMBER: THE LOT NUMBER IS UNKNOWN, HOWEVER A REVIEW OF THE CUSTOMERS PURCHASE HISTORY IDENTIFIED TWO POSSIBLE LOTS 470570 OR 711860. CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION LOW-PROFILE MANDIBULAR DISTRACTOR 13 MM CATALOG #: SP-1327 LOT #: 725000, UNKNOWN SCREWS CATALOG #: NI LOT #: NI. THERAPY DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: LOT 470570 JUL 17, 2013 AND LOT 711860 NOV 21, 2016. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00250.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A REVISION DUE TO THE DRIVE SCREW BREAKING DURING CONTROL VISIT. IT BROKE WHEN THE TURNING IS DONE. IT HAPPENED ON ONE SIDE ONLY. THE OTHER SIDE IS FINE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333041 CMF SYSTEM 30MM DRIVE SCREW W/ 65MM FLEX TUBE BONE PLATE HRS BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R