BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE CONNECT¿ PLATE FIXATION SYSTEM

    MDR report key: 19318637 · Received May 15, 2024

    Report

    Report Number
    1030489-2024-00488
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 15, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    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: PROCEDURE CHANGED FROM SURGICAL LAMINOPLASTY TO LAMINECTOMY, GUTTER CREATED ON THE LAMINA BROKE. G4: THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465, UDI# (B)(4) AND 510K# K050082 IS APPROVED FOR SALE IN US. H6: NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE CANNOT DETERMINE THE DEFINITIVE CAUSE OF 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 WITH SCREW AND PLATE HAVING CERVICAL LAMINOPLASTY ALTERNATE THERAPY FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE SCREW DID NOT WORK AND FALL OUT WHILE PLACING THE GULL WING PLATE AT C5 DURING DLAP IMPLEMENTATION. THE PLACEMENT POSITION WAS CHANGED AND THE RESCUE-SIZE SCREW WAS CHANGED, BUT STILL, THE SCREW DID NOT WORK. EVEN AFTER IT WAS REPLACED WITH A RADIUS PLATE, THE GUTTER CREATED ON THE LAMINA BROKE, MAKING IT DIFFICULT TO PLACE THE PLATE. AT THE C5, THE PROCEDURE WAS CHANGED TO LAMINECTOMY. A RADIUS PLATE WAS PLACED AT C6, BUT IT WAS DIFFICULT TO PLACE IT PROBABLY BECAUSE OF THE THICKNESS OF THE BASE OF THE SPINOUS PROCESS. THE SIZE WAS CHANGED AND IMPLEMENTED. THERE WAS A DELAY OF LESS THAN 60 MINS IN THE OVERALL PROCEDURE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE EFFECT OF THE SCREW WAS INSUFFICIENT, IT WAS RE-INSERTED, BUT AS A RESULT, THERE WAS A LEVEL WHERE IT COULD NOT BE INSERTED. THE 1 VERTEBRAL ARCH HAS BEEN CHANGED FROM SURGICAL LAMINOPLASTY TO LAMINECTOMY. BECAUSE THE SCREW WAS REINSERTED, THE PLATE WAS RESET REPEATEDLY, AND THE GUTTER CREATED WAS DAMAGED. THERE WAS NO REVISION SURGERY OCCURRED/ PLANNED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383308 CENTERPIECE CONNECT¿ PLATE FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDTRONIC SOFAMOR DANEK USA, INC G8530205 W745351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other