BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLYDESDALE PTC¿ SPINAL SYSTEM

    MDR report key: 19902536 · Received August 4, 2024

    Report

    Report Number
    1030489-2024-00926
    Event Type
    Malfunction
    Date Received
    August 4, 2024
    Date of Event
    July 9, 2024
    Report Date
    October 8, 2024
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    UDI-DI
    00643169190788
    PMA / PMN Number
    K133205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #(B)(4): PART # 4926450: LOT # 21HP VISUAL AND OPTICAL INSPECTION CONFIRMED THE IMPLANT HAS BROKEN/CRACKED AT THE INSERTER ATTACHMENT AREA. THE DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE PLACED ON THE IMPLANT DURING THE IMPLANTATION PROCEDURE. 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

    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 HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE OBLIQUE LATERAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE GRAFT STARTED TO BREAK, WHERE IT IS ATTACHED TO THE INSERTER. THE CLYDESDALE PTC 14X50MM GRAFT WAS ABOUT HALF WAY INTO THE INTERBODY SPACE AT L4/5. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951796 CLYDESDALE PTC¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 4926450 21HP 00643169190788

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male