BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE¿ SPINAL SYSTEM

    MDR report key: 14126433 · Received April 16, 2022

    Report

    Report Number
    1030489-2022-00357
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    March 24, 2022
    Report Date
    October 6, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430433
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT SOURCE: FOREIGN: (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART 7770723 ; LOT # 0870583W. ANALYSIS SUMMARY: VISUAL AND OPTICAL INSPECTION REVEALED ONE OF THE TABS/EARS OF THE IMPLANT ON THE SPACER HAS BROKEN OFF AND THE OTHER HAS BEEN BENT AND CRACKED. THERE IS NO DAMAGE PRESENT ON THE NOSE, RIBS OR BODY OF THE IMPLANT. THE IMPLANT HAS BEEN OVERLOADED AT THE TABS AND PIVOT PIN. THE IMPLANT MAY HAVE CAUGHT ON SOMETHING INSIDE THE VERTEBRAL BODY DURING THE IMPLANTATION PROCESS. 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 RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT, THE CAGE WAS ATTACHED TO THE TIP OF THE INSERTER AND WAS DRIVEN IN WITH A HAMMER. A PART OF THE CAGE WAS BROKEN WHEN IT WAS DRIVEN IN WITH A HAMMER. THERE WAS NO FRAGMENT OF BROKEN CAGE REMAINS IN PATIENT BODY. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT AND NO HOSPITALIZATION REPORTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172939 ELEVATE¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 7770723 0870583W 00643169430433

    Patients

    Seq Age Sex Outcome Treatment
    1 Female