BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH® SPINAL SYSTEM

    MDR report key: 14335315 · Received May 9, 2022

    Report

    Report Number
    1030489-2022-00446
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 1, 2022
    Report Date
    November 18, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A SIMILAR DEVICE CATALOG #828-090, 510K #K964275, AND UDI #(B)(4) IS MARKETED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H6: UPDATED. EVAL. CODE RESULT POST RADIOGRAPHIC IMAGE REVIEW RADIOGRAPHIC IMAGE REVIEW OF LATERAL XRAY AP XRAY AND ANTERIOR/ POSTERIOR TIL FUSION- A BILATERAL ROD FRACTURE IS PRESENT AT THE LEVEL OF THE VERTEBRECTOMY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING PATIENT IMPLANTED WITH RODS IN A T12 TES+3A2B PSF FOR LOWER BACK PAIN, ETC. AT T9-L2. IT WAS REPORTED THAT 16 YEARS AFTER THE INITIAL SURGERY, RODS ON BOTH SIDES WERE BROKEN. THIS IS A REPEAT SURGERY AS T12TES+3A2B PSF WAS PREVIOUSLY CARRIED OUT ON (B)(6) 2006 FOR THE METASTATIC SPINAL TUMOR (T12). THE RODS ON BOTH SIDES WERE BROKEN, SO THE BROKEN ROD NAIL REMOVAL AND THE ROD REPLACEMENT WITH A 4-ROD OPERATION WERE PERFORMED. MDT PRODUCTS WERE USED IN THE INITIAL SURGERY. THE ROD BREAKAGE IS CONSIDERED TO BE PSEUDARTHROSIS. IT IS UNKNOWN IF THE PATIENT HAD ANY SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDES THYROID CANCER. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743919 TSRH® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G828H090 W05F3676

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention