BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0X9MM FOSSA X-DR SCRW

    MDR report key: 17558862 · Received August 16, 2023

    Report

    Report Number
    0001032347-2023-00329
    Event Type
    Injury
    Date Received
    August 16, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K910038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 50MM LFT STANDARD MAND CAT# 24-6551 LOT# 452870A; TMJ SM LFT FOSSA COMP CAT# 24-6563 LOT# 446720C; 2.7X10MM HT X-DRIVE SCREW CAT# 91-2710 LOT#NI; 2.7X10MM HT X-DRIVE SCREW CAT# 91-2710 LOT#NI; 2.7X10MM HT X-DRIVE SCREW CAT# 91-2710 LOT#NI; 2.7X10MM HT X-DRIVE SCREW CAT# 91-2710 LOT#NI; 2.7X10MM HT X-DRIVE SCREW CAT# 91-2710 LOT#NI; 2.7X10MM HT X-DRIVE SCREW CAT# 91-2710 LOT#NI; 2.7X12MM HT X-DRIVE SCREW CAT#91-2712 LOT#NI; 2.0X7MM FOSSA X-DR SCRW CAT#99-6577 LOT#NI; 2.0X11MM FOSSA X-DR SCRW CAT#99-6581 LOT#NI; 2.0X11MM FOSSA X-DR SCRW CAT#99-6581 LOT#NI; THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; 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 - 2023 - 00319; 0001032347 - 2023 - 00320; 0001032347 - 2023 - 00321; 0001032347 - 2023 - 00322; 0001032347 - 2023 - 00323; 0001032347 - 2023 - 00324; 0001032347 - 2023 - 00325; 0001032347 - 2023 - 00326; 0001032347 - 2023 - 00327; 0001032347 - 2023 - 00328; 0001032347 - 2023 - 00330; 0001032347 - 2023 - 00331.

    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 THE SCREWS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TMJ PROCEDURE APPROXIMATELY 10 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAS BEEN EXPERIENCING PAIN, MOUTH DROOPING, MIGRAINES, DIFFICULTY CHEWING, AND RANGE OF MOTION ISSUES SINCE IMPLANTATION. NO MEDICAL INTERVENTION HAS BEEN NOTED AT THE TIME OF THIS REPORT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491392 2.0X9MM FOSSA X-DR SCRW CRANIOFACIAL BONE SCREW, NON-BIOABSORBABLE JEY BIOMET MICROFIXATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10