BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8501317 · Received April 10, 2019

    Report

    Report Number
    0001032347-2019-00216
    Event Type
    Injury
    Date Received
    April 10, 2019
    Report Date
    July 15, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053314
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00526-3 & 0001032347-2019-00215-1.

    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 PRODUCT: BIOMET MICROFIXATION HIGH TORQUE CROSS-DRIVE SCREW, CATALOG #: 91-1511, LOT #: UNK; BIOMET MICROFIXATION HIGH TORQUE CROSS-DRIVE SCREW, CATALOG # 91-1515, LOT #: UNK; OXFORD PERFORMANCE MATERIALS (OPM) HTR-PEKK HENRIKSEN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANT, CATALOG #: PK620898, LOT #: 060818; OXFORD PERFORMANCE MATERIALS (OPM) HTR-PEKK HENRIKSEN RTIGH MAXILLA IMPLANT, CATALOG #: PK620905, LOT #: 060818. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION; IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION WITHOUT THE KNOWN SCREW PART NUMBERS WAS COMPLETED: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DISTRIBUTOR REPORTED THAT THE PATIENT DEVELOPED AN INFECTION APPROXIMATELY ONE WEEK POST-OPERATIVELY. THE DISTRIBUTOR ALSO REPORTED THAT THE TYPE OF INFECTION WAS UNKNOWN, THE INFECTION WAS TREATED WITH ANTIBIOTICS, AND THERE ARE NO PLANS TO REVISE. NO PRODUCT WAS RETURNED AS THE PRODUCT REMAINS IMPLANTED. NO INSPECTIONS OR TESTING COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIANS REPORTS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE TYPE OR CAUSE OF THE INFECTION. THE IMPLANTS IN THIS COMPLAINT ARE PROVIDED UNSTERILE AND ARE MEANT TO BE STERILIZED BY THE FACILITY UPON RECEPTION OF THE PRODUCT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART NUMBERS AND LOT NUMBERS OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ONCE THE INVESTIGATION HAS BEEN COMPLETED AGAIN WITH THE NEW SCREW PART NUMBERS, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00526 & 0001032347-2019-00215.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY ONE (1) WEEK AFTER IMPLANTATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION RESOLVED. THERE IS NO REVISION PLANNED. THERE IS NO KNOWN HISTORY OF INFECTION AT THE FACILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292274 "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW SCREW, FIXATION, BONE JEY BIOMET MICROFIXATION N/A UNK 00841036053314

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention