BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 20244297 · Received September 18, 2024

    Report

    Report Number
    1030489-2024-01162
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 18, 2024
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 5430030, SERIAL/LOT #: (B)(6), UDI#: (B)(4) ; PRODUCT ID: 5430030, SERIAL/LOT #: (B)(6), UDI#: (B)(4) ; PRODUCT ID: 7068396, SERIAL/LOT #: (B)(6), UDI#: (B)(4), PRODUCT ANALYSIS # (B)(4): PRODUCT ID 7068396 :LOT # H5943768, PRODUCT ID: 5430030, LOT #: H5837097 PRODUCT ID: 5430030, LOT #: H5886859, PRODUCT ID: 7068396, LOT #: H5938322. VISUAL AND OPTICAL INSPECTION CONFIRMED THE SCREW WAS RETURNED WITH THREAD DAMAGE AND THE BREAK OFF PORTION STILL ATTACHED. FUNCTIONAL INSPECTION WITH A SAMPLE BREAK OFF INSTRUMENT CONFIRMED THE BREAK OFF PORTION OF THE SCREW WAS ABLE TO BE REMOVED AS INTENDED. THE DAMAGE TO THE THREADS APPEARS TO BE FROM MISALIGNMENT DURING THE THREADING PROCESS. SECTION E : INITIAL REPORTER IS UNKNOWN G4: THE REPORTED PARTS IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7540020, 510K # K052187 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF FOR SPONDY LOLISTHESIS. IT WAS REPORTED THAT AFTER SCREW INSERTION, TEMPORARY ROD FIXATION, AND CROSS-LINK INSTALLATION, THE SCREW CANNOT BE BROKEN OFF AT THE TIME OF THE FINAL TIGHTENING OF THE SET SCREW. SET SCREW COULD NOT BE TWISTED AT THE FINAL FASTENING. THE SET SCREW WAS CHANGED 5 TIMES, BUT THE SCREW COULD NOT BE BROKEN OFF; THE CROSS-LINK AND ROD WERE REMOVED, THE SCREW WAS REPLACED WITH A NEW ONE, THE ROD AND CROSS-LINK WERE REPLACED, AND THE FINAL TIGHTENING WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384409 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 7068396 H5943768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."