BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNEX(TM) WITH LARGE ENDPLATE 20 DEG/37MM-55MM HEIGHT

    MDR report key: 7863564 · Received September 11, 2018

    Report

    Report Number
    2939274-2018-53693
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    January 1, 2008
    Report Date
    August 21, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MQP
    UDI-DI
    10705034785110
    PMA / PMN Number
    K003836
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS 6 FEET. UNKNOWN DATE IN 2008. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS AN ATTORNEY. PART 495.323, LOT 1810184: MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: JANUARY 16, 2008. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY WAS PERFORMED ON (B)(6) 2008, FOR TREATMENT A L5 POSTERIOR RESECTION DUE TO A HEMANGIOMA WITH A L4-S1 POSTERIOR FUSION. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH THE (USS) UNIVERSAL SPINE SYSTEM IMPLANTS. THE PATIENT WAS IMPLANTED WITH ONE (1) 6.0MM/ 200MM TI ROD THAT WAS CUT IN HALF TO CONSTRUCT TWO RODS, TWO (2) TI LOW PROFILE TRANS-CONNECTORS, FOUR (4) NUTS, FOUR (4) COLLARS, TWO (2) 8MM X 55MM SCREWS AND TWO (2) 9MM X 50MM SCREWS. ON (B)(6) 2008 PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A FOLLOW-UP PROCEDURE, WHERE THE PATIENT WAS IMPLANTED WITH ONE (1) SYNEX CAGE IMPLANT AT THE L5 SPINE DISC SPACE LEVEL. POST-OPERATIVE, THE PATIENT PRESENTED WITH A LUMBAR SPINE INFECTION. ON (B)(6) 2008, SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE TO ADDRESS THE PATIENT'S INFECTION. NO PUS WAS FOUND INTRAOPERATIVELY. TISSUES APPEARED HEALTHY. CULTURES TAKEN DURING SURGERY WERE REPORTED WITH NO ORGANISMS SEEN ON GRAM STAIN. SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704120 SYNEX(TM) WITH LARGE ENDPLATE 20 DEG/37MM-55MM HEIGHT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP WRIGHTS LANE SYNTHES USA PRODUCTS LLC 495.323 1810184 10705034785110

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention