BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH C TITANIUM MESH

    MDR report key: 9243289 · Received October 26, 2019

    Report

    Report Number
    1030489-2019-01216
    Event Type
    Injury
    Date Received
    October 26, 2019
    Report Date
    October 26, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    EZX
    PMA / PMN Number
    SEE H10
    Adverse Event
    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 # 905-166, 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. ALTHOUGH IT IS UNKNOWN WHETHER THIS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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 VERTEBRAL BODY FRACTURE AND UNDERWENT OSTEOTOMY. REPLACEMENT OF VERTEBRAL BODY WAS PERFORMED FROM THE ANTERIOR SIDE. AFTER CHANGING THE POSITION, FIXATION WAS PERFORMED AT 3 LEVELS ABOVE AND 3 LEVELS BELOW THE TREATED LEVEL FROM THE POSTERIOR SIDE. ON AN UNKNOWN DATE, POST-OP, PATIENT SUFFERED WITH INFECTION AT THE SURGICAL SITE. THE CAUSE OF INFECTION WAS NOT KNOWN TO THE SURGEON. A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2019. IT IS UNKNOWN WHETHER THIS RE-OPERATION HAS BEEN PERFORMED YET OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037438 PYRAMESH C TITANIUM MESH MESH, METAL EZX WARSAW ORTHOPEDICS NA 0534630W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention