BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    MDR report key: 8473312 · Received April 2, 2019

    Report

    Report Number
    0001032347-2019-00197
    Event Type
    Injury
    Date Received
    April 2, 2019
    Report Date
    August 11, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053321
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    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. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. FOR PART #91-1515 IN THE PREVIOUS ONE YEARS (FROM THE NOTIFICATION DATE),SIMILAR COMPLAINTS HAVE YIELDED A COMPLAINT RATE OF 0.84%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - OPM HTR-PEKK IMPLANT CATALOG #:PK620898, LOT #: 060818; OPM HTR-PEKK IMPLANT CATALOG #: PK620905, LOT #: 060818. 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: 0001032347-2019-00195 & 0001032347-2019-00196.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE IS A REVISION PLANNED DUE TO INFECTION. THE PATIENT HAD AN INFECTION APPROXIMATELY ONE WEEK POST-OP. AT THAT TIME, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION WAS THOUGHT TO HAVE BEEN RESOLVED. THE PATIENT IS NOW INFECTED AGAIN AND COLONIZED WITH (B)(6), WITH PLAN TO REMOVE THE MALAR IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION WAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268648 "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW SCREW, FIXATION, BONE JEY BIOMET MICROFIXATION N/A UNK 00841036053321

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R