BEUDAMED
    FDA Adverse Event Injury Summary report: N

    55MM LFT STANDARD MAND

    MDR report key: 11256600 · Received January 31, 2021

    Report

    Report Number
    0001032347-2021-00030
    Event Type
    Injury
    Date Received
    January 31, 2021
    Date of Event
    September 29, 2020
    Report Date
    July 30, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATIONO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOW UP INFORMATION SUGGESTS THAT THE PATIENT'S CONDYLE KICKED OUT LATERALLY POST OP. SURGEON REALIZED THE MANDIBULAR COMPONENT WAS TOO LONG AND OPTED TO REPLACE IT WITH A SHORTER ONE. THE PROBLEM WAS RESOLVED. HOWEVER, WITHOUT MEDICAL RECORDS A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION 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

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TMJ PROCEDURE APPROXIMATELY TEN (10) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO (2) WEEKS LATER DUE TO THE DOCTOR WANTING TO PUT IN A SMALLER IMPLANT AS THE ORIGINAL DEVICE WAS TOO LARGE FOR THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# UNK LEFT MANDIBLE; LOT# UNK. ITEM# 24-6563 TMJ SM LFT FOSSA COMP; LOT# UNK. ITEM# 70-2001 HIGH TORQUE DRIVER; LOT# UNK. ITEM# 70-2001 HIGH TORQUE DRIVER; LOT# UNK. ITEM# 50-1010 BATTERY POWERDRIVER P2; LOT# UNK. ITEM# 50-1010 BATTERY POWERDRIVER P2; LOT# UNK. ITEM# 01-0298 OMNIMAX ARCH BAR; LOT# UNK. ITEM# 01-0298 OMNIMAX ARCH BAR; LOT# UNK. ITEM# 91-5707 OMNIMAX SD XD SCREW 2.0X7MM; LOT# UNK. ITEM# 91-5707 OMNIMAX SD XD SCREW 2.0X7MM; LOT# UNK. ITEM# 91-5709 OMNIMAX SD XD SCREW 2.0X9MM; LOT# UNK. ITEM# 91-5709 OMNIMAX SD XD SCREW 2.0X9MM; LOT# UNK. ITEM# 91-5709 OMNIMAX SD XD SCREW 2.0X9MM; LOT# UNK. ITEM# 91-5709 OMNIMAX SD XD SCREW 2.0X9MM; LOT# UNK. ITEM# 91-5709 OMNIMAX SD XD SCREW 2.0X9MM; LOT# UNK. ITEM# 91-5709 OMNIMAX SD XD SCREW 2.0X9MM; LOT# UNK. ITEM# 91-5709 OMNIMAX SD XD SCREW 2.0X9MM; LOT# UNK. ITEM# 24-6610 DRILL 1.5X50 11 STP J-NTCH; LOT#UNK. ITEM# 24-6614 DRILL 2.0X70 12STP J-NTCH; LOT# UNK. ITEM# 24-6530 TMJ DIAMOND BURR COARSE; LOT# UNK. ITEM# 99-6579 2.0X9MM FOSSA X-DR SCRW; LOT# UNK. ITEM# 99-6579 2.0X9MM FOSSA X-DR SCRW; LOT# UNK. ITEM# 99-6579 2.0X9MM FOSSA X-DR SCRW; LOT# UNK. ITEM# 99-6579 2.0X9MM FOSSA X-DR SCRW; LOT# UNK. ITEM# 91-2710 2.7X10MM HT X-DRIVE SCREW; LOT# UNK. ITEM# 91-2710 2.7X10MM HT X-DRIVE SCREW; LOT# UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF LEFT TMJ PROCEDURE TWO (2) WEEKS POST IMPLANTATION DUE TO UNKNOWN REASON. DURING REVISION PROCEDURE IT WAS NOTED THAT ONLY THE MANDIBLE WAS REMOVED AND REPLACED WITH A SMALLER MANDIBLE DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153090 55MM LFT STANDARD MAND IMPLANT LZD BIOMET MICROFIXATION N/A 854200D

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R