BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7X10MM HT X-DRIVE SCREW

    MDR report key: 12638342 · Received October 15, 2021

    Report

    Report Number
    0001032347-2021-00483
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    March 11, 2021
    Report Date
    October 15, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K001238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 55MM LFT STANDARD MAND PART#24-6556 LOT#538170A TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE, PART# 24-6545, LOT# 539270A TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL, PART# 24-6562, LOT# 547100B TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL, PART# 24-6563, LOT# 532100B 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 8MM, PART# 91-2708, LOT# NI I 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 12MM, PART# 91-2712, LOT# NI TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM, PART# 99-6579, LOT# NI 2.7MM SYSTEM EMERGENCY CROSS DRIVE SCREW, 1/PKG 3.2X8MM, PART# 99-9948, LOT# NI 2.7MM SYSTEM EMERGENCY CROSS DRIVE SCREW, 1/PKG 3.2X10MM, PART# 99-9950, LOT# NI 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347 - 2021- 00321, 0001032347- 2021- 00322 , 0001032347- 2021- 00323 , 0001032347- 2021- 00324, 0001032347 - 2021 - 00482, 0001032347 - 2021 - 00484, 0001032347 - 2021 - 00485, 0001032347 - 2021 - 00486, 0001032347 - 2021 - 00487.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS SEVEN (7) YEARS FOLLOWING IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538128 2.7X10MM HT X-DRIVE SCREW CRANIOFACIAL BONE SCREW, NON-BIOABSORBABLE, STERILE HWC BIOMET MICROFIXATION N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R