BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    MDR report key: 8516063 · Received April 15, 2019

    Report

    Report Number
    0001032347-2019-00223
    Event Type
    Injury
    Date Received
    April 15, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036088873
    PMA / PMN Number
    K113512
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. BASED ON THE VENDOR COMPLAINT REPORT, IT WAS DETERMINED THAT THE ORTHOGNATHIC MOVEMENTS DID NOT MATCH THE VSP, THE COMPLAINT IS CONFIRMED. THEY PROPOSED THIS WAS DUE TO THE LEFORT OSTEOTOMY OF THE MAXILLA ON THE POSTOP SCAN DIFFERING FROM THE PLANNED ONE. NO X-RAYS, SCANS, PHOTOGRAPHS, OR PHYSICIAN REPORTS WERE PROVIDED. THE PRODUCT WAS NOT RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. THE DESIGN VENDOR REVIEWED THE DIGITAL DESIGN OF THE LEFT FOSSA AND MANDIBLE IMPLANTS AND MARKING GUIDES AND DETERMINED THAT THEY FIT CORRECTLY TO THE PATIENT'S ANATOMY, THE SCREW HOLE LOCATIONS WERE CORRECT, AND THE PRODUCTS WERE THEREFORE CONFORMING TO DESIGN SPECIFICATIONS (470-500). DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE SCREWS INVOLVED IN THE EVENT IS UNKNOWN. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THIS MAY HAVE BEEN DUE TO LEFORT MARKING GUIDES NOT HAVING BEEN REQUESTED/PROVIDED. INTERMEDIATE AND FINAL SPLINTS WERE PROVIDED, AND A DIGITAL REVIEW BY THE VENDOR FOUND THEM TO BE CONFORMING TO WI 470-906. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION CUSTOM MADE TMJ CATALOG #: TMJPM-1944, LOT #: 812610; BIOMET MICROFIXATION SCREW CATALOG #: 91-2714, LOT #: UNKNOWN; BIOMET MICROFIXATION SCREW CATALOG #: 91-2716, LOT #: UNKNOWN. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00171, 0001032347-2019-00221 & 0001032347-2019-00222.

    Description of Event or Problem · 1

    IT WAS REPORTED A REQUEST FOR A CUSTOM IMPLANT WAS RECEIVED, INDICATING THAT A REVISION WILL OCCUR. THE REVISION IS PLANNED BECAUSE THE MANDIBLE COMPONENT HAS BECOME DISLOCATED FROM THE FOSSA COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308356 "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A UNK 00841036088873

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R