BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 10533371 · Received September 15, 2020

    Report

    Report Number
    2647346-2020-00028
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 27, 2020
    Report Date
    March 16, 2021
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    KWP
    UDI-DI
    00721902989322
    PMA / PMN Number
    K042922
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS SUMMARY: VISUAL AND OPTICAL INSPECTION OF PART # 9790215 LOT # H5540481 DID NOT REVEAL ANY DAMAGE TO THE THREADS OF HEAD OF THE SCREW. DIMENSIONAL INSPECTION CONFIRMED THE SCREW WAS MADE TO PRINT. THE SCREW APPEARS TO FUNCTION AS INTENDED. NO FAULT FOUND. 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

    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 A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH A PRE-OPERATIVE DIAGNOSIS OF CERVICAL FRACTURE. IT WAS REPORTED THAT AFTER THE FIRST SURGERY, THE PATIENT DEVELOPED NEUROLOGIC SYMPTOMS AND UNDERWENT A REVISION SURGERY THE NEXT DAY TO REMOVE THE FOUR SCREWS OF THE FIRST SURGERY. THE PRODUCTS HAVE BEEN IMPLANTED IN THE PATIENT, AND THE LARGER DIAMETER SCREWS HAVE BEEN USED DURING THE SECONDARY REVISION SURGERY. THE SIZE OF THE SCREW IMPLANTS THAT WERE IMPLANTED DURING THE REVISION SURGERY WAS WITH DIAMETER OF 4.5. THE SECOND REVISION SURGERY WAS PERFORMED WITHIN 24 HOURS AFTER THE FIRST SURGERY, AND THESE SCREWS CAN NO LONGER BE USED. THERE WAS NO DEVICE BREAKAGE AND PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998640 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT PUERTO RICO OPERATIONS CO, MED REL 9790215 H5540481 00721902989322

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention