BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE PTC¿ SPINAL SYSTEM

    MDR report key: 21570930 · Received March 11, 2025

    Report

    Report Number
    1030489-2025-01283
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    December 21, 2022
    Report Date
    March 11, 2025
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    UDI-DI
    00643169187290
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART# 3993213 LOT# H5225201 VISUAL AND MICROSCOPIC INSPECTION REVEALED THAT THE THREADS THAT CONNECT THE SPACER TO THE INSERTER HAVE BEEN CROSS THREADED/STRIPPED. WITNESS MARKS ARE NOTED ON THE SCALLOPED AREAS ON THE SPACER FROM WHAT APPEARS TO BE THE INSTALLATION OF THE SPACER. IT APPEARS THE THREADS WERE OVERLOADED DURING THE INSTALLATION PROCESS. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE IMPLANT WOULD NOT APPROPRIATELY THREAD ONTO THE INSERTER. IT WAS UNDETERMINED IF THE IMPLANT WAS SUFFICIENTLY CAPTURED BECAUSE IT WAS NOT SITTING FLUSH WITH THE INSERTER AND THEREFORE ANOTHER IMPLANT WAS OPENED TO COMPLETE THE PROCEDURE. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149446 CAPSTONE PTC¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 3993213 H5225201 00643169187290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown