BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 12368984 · Received August 26, 2021

    Report

    Report Number
    1030489-2021-01084
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 2, 2021
    Report Date
    February 16, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: AFTER VISUAL AND OPTICAL EXAMINATION AND FUNCTIONAL TESTING, IT DOES NOT APPEAR TO BE ANY DAMAGE, NOR DOES IT INDICATE ANY FUNCTIONAL ISSUES WITH THE SCREW. 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

    COUNTRY: (B)(6). THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465, 510K# K050082 AND UPN#00721902742743 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C6 LAMINOPLASTY FOR CSR. IT WAS REPORTED THAT OPEN DOOR PLATE WAS SELECTED WHEN PERFORMING C6 LAMINOPLASTY. FIRST, IT WAS INSERTED A 2.5 X 7 MM SCREW ON THE CRANIAL SIDE OF THE LATERAL MASS. IT WAS SAID THAT THE SCREW WAS NOT VERY EFFECTIVE, AND IT'S HARD TO INSERT. NEXT, 2.5 X 5 MM WAS INSERTED TO THE CAUDAL SIDE, BUT THE SCREW WAS NOT EFFECTIVE. THEY CHANGED THE SCREW DIAMETER TO 3.0 AND INSERTED IT, BUT THE SCREW WAS NOT EFFECTIVE. IN BOTH CASES, THE SCREW DID NOT PROCEED WELL WHEN IT WAS INSERTED INITIALLY, AND THE SCREWS WERE DIFFICULT TO INSERT. ALL THE SCREWS WERE REPLACED WITH DIFFERENT ONES AND CHANGED THE PLATE TO A LATERAL HOLE. ANOTHER PILOT HOLE WAS CREATED AND THE PLATE WAS FINALLY STABLE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267375 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS G9010000274 0834125W

    Patients

    Seq Age Sex Outcome Treatment
    1 Male