BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 21196977 · Received January 21, 2025

    Report

    Report Number
    1030489-2025-00295
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    November 23, 2022
    Report Date
    January 21, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    UDI-DI
    00613994291042
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN - CHINA H3: PRODUCT ANALYSIS #PRODUCT ID:2990822, LOT# H5732933. VISUAL AND MICROSCOPIC INSPECTION REVEALED SIGNIFICANT TORSIONAL/TWISTING DEFORMATION TO THE BODY OF THE IMPLANT. THE THREADS THAT CONNECT THE SPACER TO THE INSERTER HAVE BEEN STRIPPED. 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 A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN POSTERIOR LUMBAR INTERBODY FUSION SURGERY (PLIF). IT WAS REPORTED THAT THERE WERE TWO TARGET SEGMENTS, AND WHEN THE SECOND CAPSTONE WAS APPLIED, THE FLUOROSCOPY FOUND THAT THE DEPTH OF THE CAPSTONE WAS NOT IDEAL. THE CAPSTONE WAS ATTEMPTED TO BE TAKEN OUT, AND DURING THE REMOVAL WITH A SLIDE HAMMER, THE POSTERIOR EDGE OF THE CAPSTONE WAS BROKEN. LATER, REPLACED WITH A NEW CAPSTONE TO USE AND THE SURGERY WAS COMPLETED. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR SPINAL STENOSIS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY. THERE WAS A DELAY OF ABOUT 15 MINUTES IN THE OVERALL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669464 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MDT SOFAMOR DANEK PUERTO RICO MFG 2990822 H5732933 00613994291042

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown