BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH C TITANIUM MESH

    MDR report key: 10204273 · Received June 27, 2020

    Report

    Report Number
    1030489-2020-00735
    Event Type
    Injury
    Date Received
    June 27, 2020
    Report Date
    June 27, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    EZX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 905-133, 510K # K011406 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-C6 AND CORPECTOMY WAS PERFORMED AT C5. ON AN UNKNOWN DATE, POST-OP, SINKING OF THE REPORTED IMPLANT WAS OBSERVED. THE PATIENT SOMETIMES HAD A RIGHT SHOULDER PAIN AROUND THE TIME WHEN SINKING OF THIS IMPLANT WAS REPORTED. ADDITIONALLY, BACKING-OUT OF 4 SCREWS WAS ALSO REPORTED. HENCE, ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY. IN THIS SURGERY, ALTHOUGH THERE WAS SINKING OF THE DEVICE, IT APPEARED TO BE FIT IN ITS POSITION; HENCE, IT WAS NOT REMOVED AND WAS LEFT IMPLANTED IN THE PATIENT'S BODY. THE 4 BACKED-OUT SCREWS WERE REMOVED AND LONGER SCREWS WERE INSERTED. THE ANTERIOR PLATE (THAT WAS INSERTED IN THE PREVIOUS SURGERY) CAME OFF TOGETHER WITH THE SCREWS AND WAS USED AGAIN BY PERFORMING FIXATION WITH LONGER SCREWS. "LMS" WAS INSERTED FROM POSTERIOR SIDE INTO C4-C6 AND WAS FASTENED WITH ROD AND CROSSLINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668204 PYRAMESH C TITANIUM MESH MESH, METAL EZX WARSAW ORTHOPEDICS NA 0736627W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention