BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX® RECONSTRUCTION SYSTEM

    MDR report key: 19742543 · Received July 15, 2024

    Report

    Report Number
    1030489-2024-00827
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 15, 2024
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT: OTHER - INFECTION G4: THIS PRODUCT IS NOT APPROVED IN UNITED STATES. HOWEVER, SIMILAR PRODUCT- 6950315, UAN-00885074451237 AND 510 (K)- K052180 IS APPROVED IN UNITED STATES. H6 - 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED SCREW HAVING O-C4 FIXATION THERAPY FOR DECUBITUS INFECTION. IT WAS REPORTED THAT THE SET SCREW OF THE RIGHT OCCIPITAL PLATE AND THE SET SCREW OF THE C4 SCREW DISLODGED. THE ROD WAS SEPARATED FROM THE HEAD OF THE OCCIPITAL BONE PLATE, CAUSING BEDSORES IN THE OCCIPITAL REGION. IN ADDITION, THERE WAS AN INFECTION. THIS EVENT WAS REPEAT SURGERY BECAUSE THERE WAS DEBRIDEMENT AND REMOVAL DUE TO DECUBITUS INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE REVISION SURGERY OCCURRED DUE TO INFECTION WAS RELATED TO THE PRODUCTS REPORTED AND THERE WAS NO MALFUNCTION ASSOCIATED WITH THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459266 VERTEX® RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G6950315 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R