BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 19536197 · Received June 14, 2024

    Report

    Report Number
    1030489-2024-00678
    Event Type
    Injury
    Date Received
    June 14, 2024
    Report Date
    June 14, 2024
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    UDI-DI
    00613994579614
    PMA / PMN Number
    K091974
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2024 MPXR 1182551 (REP, HCP): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 POSTERIOR DECOMPRESSION AND SPINAL FUSION THERAPY FOR LUMBAR RADICULOPATHY. LEVELS IMPLANTED L4-S1 IT WAS REPORTED THAT THE DEVICE HAS BROKEN AND UPON EXPLANATION, THE L4 SET SCREW WAS FOUND TO BE LOOSE AND METAL SHAVINGS FROM THE ROD / SET SCREW INTERFACE WERE FOUND AROUND THE HEAD OF THE SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT NO FRAGMENTS/ SHAVINGS FROM SET SCREW WERE IRRIGATED AND SUCTIONED AWAY FROM PATIENT, HENCE NO FRAGMENTS REMAINED. PATIENT WAS BROUGHT TO OR FOR AND EXTENSION OF FUSION. UPON SURGICAL EXPOSURE, THE SET SCREW WAS FOUND TO BE LOOSE. DUE TO PSEUDOARTHROSIS L4/5, LOOSENING OF THE L4 SCREW IN THE BONE AND ADJACENT LEVEL DISEASE( POSSIBLE INFECTION), THE HARDWARE WAS REPLACED AND EXTENDED UP TO L3. PATIENT ALSO HAD POSSIBLE DISC DEGENERATION OF L3/4 DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394738 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 54840006545 H5490028 00613994579614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R