BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA 5.5/6.0

    MDR report key: 19151213 · Received April 22, 2024

    Report

    Report Number
    1030489-2024-00301
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    April 3, 2024
    Report Date
    May 29, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00613994429742
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. 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.

    Additional Manufacturer Narrative · 0

    D4: LOT# UPDATED POST ANALYSIS H3: PRODUCT ANALYSIS PART# 5480004V ; LOT# K23E3092- VISUAL EXAMINATION CONFIRMED THAT THE INSTRUMENT TIP HAS BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS. OPTICAL INSPECTION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT DUCTILE FRACTURE WITH CIRCULAR MATERIAL FLOW. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. H6: UPDATED EVAL. CODE METHOD AND EVAL. CODE RESULT POST ANALYSIS UPDATED ANNEX G CODE POST ANALYSIS 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 A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW USING A DRIVER IN A PLIF AND HARDWARE REMOVAL FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT WHILE TAKING OUT A SCREW, THE DRIVER SNAPPED OFF INSIDE THE TULIP HEAD OF THE SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE REPORTED PRODUCT WAS ALREADY USED MULTIPLE TIMES PREVIOUSLY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259525 CD HORIZON SOLERA 5.5/6.0 SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 5480004V K23E3092 00613994429742

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male