BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 1.8 X 5MM

    MDR report key: 10508286 · Received September 9, 2020

    Report

    Report Number
    0001032347-2020-00431
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 26, 2020
    Report Date
    March 31, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053345
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR TWO OF THE REPORTED SCREWS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00404, 0001032347-2020-00405, 0001032347-2020-00406, 0001032347-2020-00430. MEDICAL PRODUCTS : HTR*PMI 2025734 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT, PART# PM623210-B, LOT# 986060. 1.5MM SYSTEM 6 HOLE EXTRA LONG DOUBLE Y PLATE, PART# 01-7114, LOT# J416200. 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK, PART# 91-6104, LOT# J416220. 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCREW 1.5MM X 5MM, PART# 91-6105, LOT# NI. 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 1.8 X 5MM, PART# 91-1805, LOT# NI. (B)(6). THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED A CUSTOM CRANIOPLASTY PLATE WAS REMOVED DUE TO NECROSIS TWO (2) MONTHS AFTER IMPLANTATION. A FEW DAYS AFTER SURGERY, A BRUISE WAS OBSERVED IN THE SKIN OVER THE MIDDLE OF THE IMPLANT, AND THE BRUISE DID NOT IMPROVE. TWO (2) WEEKS PRIOR TO REMOVAL, THE SPOT ON THE SKIN OPENED UP WITH FLUID ESCAPING. IT HAS NOT BEEN DETERMINED IF THE BACK-UP IMPLANT WILL BE USED OR IF A NEW CUSTOM PLATE WILL BE IMPLANTED IN THE COMING MONTHS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971837 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 1.8 X 5MM PLATE, BONE JEY BIOMET MICROFIXATION N/A UNK 00841036053345

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R