BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER CERVICAL PLATING SYSTEM

    MDR report key: 20470580 · Received October 17, 2024

    Report

    Report Number
    3005031160-2024-00035
    Event Type
    Injury
    Date Received
    October 17, 2024
    Report Date
    October 17, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    KWQ
    PMA / PMN Number
    K170224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS NOTIFIED OF THIS COMPLAINT ON (B)(6) 2024. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE COMPLAINANT. THE DEVICE WAS UNABLE TO BE RETURNED FOR EVALUATION. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING RECORDS WAS UNABLE TO BE PERFORMED AS THE PART AND LOT INFORMATION FOR THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. NO FURTHER INVESTIGATION WAS ABLE TO BE COMPLETED AT THIS TIME. THE IFU FOR SPIDER CERVICAL PLATING SYSTEM STATES "THE SPIDER SYSTEM IS ONLY A TEMPORARY IMPLANT USED FOR THE CORRECTION AND STABILIZATION OF THE CERVICAL SPINE. THE SYSTEM IS ALSO USED TO AUGMENT THE DEVELOPMENT OF A SPINAL FUSION BY PROVIDING TEMPORARY STABILIZATION. THIS DEVICE IS NOT INTENDED TO BE THE SOLE MEANS OF SPINAL SUPPORT." ADDITIONALLY, THE IFU WARNS "AFTER THE SPINE IS FUSED, THESE DEVICES SERVE NO FUNCTIONAL PURPOSE AND SHOULD BE REMOVED. IF THE DEVICE IS NOT REMOVED FOLLOWING COMPLETION OF ITS INTENDED USE, ONE OR MORE OF THE FOLLOWING COMPLICATIONS MAY OCCUR: (1) CORROSION, WITH LOCALIZED TISSUE REACTION OR PAIN, (2) MIGRATION OF IMPLANT POSITION POSSIBLY RESULTING IN INJURY, (3) RISK OF ADDITIONAL INJURY FROM POSTOPERATIVE TRAUMA, (4) BENDING, LOOSENING, AND/OR BREAKAGE, WHICH COULD MAKE REMOVAL IMPRACTICAL OR DIFFICULT, (5) PAIN, DISCOMFORT, OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE." IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY FOR ANTERIOR FIXATION OF THE CERVICAL SPINE IN 2016. THE PATIENT REPORTED PAIN AND TROUBLE SWALLOWING AND A FOLLOW UP MRI PERFORMED IN 2023 REVEALED THE PLATING DEVICE WAS BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463602 SPIDER CERVICAL PLATING SYSTEM Appliance, fixation, spinal intervertebral body KWQ XTANT MEDICAL HOLDINGS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R