BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 21343720 · Received February 10, 2025

    Report

    Report Number
    1030489-2025-00668
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Report Date
    February 10, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PMA / 510(K) #: THIS DEVICE IS NOT MARKETED IN UNITED STATES, HOWEVER A SIMILAR DEVICE WITH PRODUCT ID: 3120215, UDI: (B)(4), 510(K)# K063100 IS MARKETED 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. H11: THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 HAVING A REVISION SURGERY FOR NAIL REMOVAL. IT WAS REPORTED THAT THE INITIAL SURGERY HAPPENED ON (B)(6) 2020 AT C5/6. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS CSM. BONE FUSION WAS ACHIEVED. REVISION SURGERY WAS PERFORMED FOR NAIL REMOVAL. SCREW FRACTURED DURING PROCEDURE. THE TIP OF THE SCREW REMAINED ABOUT 5-6 MM IN THE VERTEBRAL BODY AND WAS DIFFICULT TO REMOVE, SO IT WAS LEFT THERE. PRODUCT EXPLANTED PARTIALLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WILL NOT BE RETURNED AS THE CUSTOMER REFUSED RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609504 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD KWQ MDT SOFAMOR DANEK PUERTO RICO MFG G9790213 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown