BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE CONTROL PTC¿ SPINAL SYSTEM

    MDR report key: 12445191 · Received September 9, 2021

    Report

    Report Number
    1030489-2021-01137
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 20, 2021
    Report Date
    June 6, 2022
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    K171107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 5011327 ; LOT # H5401318 ANALYSIS SUMMARY: VISUAL AND OPTICAL INSPECTION CONFIRMED THE THREADS ON THE SPACER ARE STRIPPED. THERE IS NO DAMAGE ON THE OUTER SURFACE OF THE SPACER THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING L2-S2AI-PSF, L4/5-PLIF. THE PRE-OPERATIVE DIAGNOSIS WAS MENTIONED AS LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT, IT SEEMED THAT THE THREAD WAS DAMAGED WHEN INSERTING INTO THE INTERVERTEBRAL SPACE. AN ATTEMPT WAS MADE TO CONNECT AGAIN, BUT IT COULDN'T BE PERFORMED, SO THE PRODUCT WAS REPLACED WITH A NEW ONE. THE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT. THE LEVELS IMPLANTED WERE MENTIONED AS L2-S2AI. THE STATUS OF CAGE WAS MENTIONED AS ¿EXPLANTED-COMPLETE¿. THE THREAD OF THE CAGE GRIPPING BY THE INSERTER WAS BROKEN. THE REPORTED DAMAGED THREAD IS OF THE IMPLANT, NOT OF THE INSERTER. NEW INSERTER AND NEW CAGE WAS USED AND PROCEDURE WAS COMPLETED. PATIENT MEDICAL HISTORY INCLUDES HT, DM, CEREBRAL INFARCTION, TWO-SIDED TKA, DVT. THERE WAS NO HEALTH DAMAGE IN PATIENT REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342383 CAPSTONE CONTROL PTC¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MDT SOFAMOR DANEK PUERTO RICO MFG 5011327 H5401318

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female