BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH® SPINAL SYSTEM

    MDR report key: 24141952 · Received January 22, 2026

    Report

    Report Number
    3014725904-2026-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 26, 2025
    Report Date
    March 3, 2026
    Manufacturer
    MEDTRONIC MEDICAL COSTA RICA S.R.L.
    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

    H6: FDM HAS BEEN UPDATED. 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

    E: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. G2: COUNTRY OF ORIGIN IS JAPAN. G4 510(K)#: PLEASE NOTE THAT THIS PRODUCT: G9010001599 (SET SCREW: G9010001599 BREAKOFF) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE 6534530 (SET SCREW PACK 6534530 4 PACK SET SCREW) WITH 510(K)#: K170679. THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS. 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 A PATIENT HAVING POSTERIOR CORRECTION AND FIXATION SPINAL THERAPY FOR IDIOPATHIC SPONDYLOSIS. IT WAS REPORTED THAT THE SET SCREW DOES NOT FIT INTO T-BOLT. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IT IS UNKNOWN WHY SET SCREW DID NOT FIT INTO T-BOLT, MAYBE IT WAS CAUSED BY THE DEFORMATION OF THREAD. THIS EVENT OCCURRED DURING THE INSERTION OF THE SET SCREW INTO THE T-BOLT PRIOR TO PLACEMENT IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REASON WHY THE SET SCREW DID NOT INSERT INTO T-BOLT IS UNKNOWN AND THE ISSUE MAY BE CAUSED DUE TO DEFORMATION OF THREADS BUT NO DEFORMATION OR SCARS HAVE BEEN OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304543 TSRH® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDTRONIC MEDICAL COSTA RICA S.R.L. G9010001599 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown