BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 12203761 · Received July 21, 2021

    Report

    Report Number
    1030489-2021-00962
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 28, 2021
    Report Date
    January 6, 2022
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    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

    H3: DEVICE EVALUATED SUMMARY- VISUAL AND OPTICAL EXAMINATION OF THE RETURNED IMPLANT REVEALED THE FEMALE HEX OF THE SCREW HAS BEEN DAMAGED AND DEFORMED. THE HEX EDGES HAVE BEEN ROUNDED OFF AND STRIPPED. 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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG# 9791223 AND 510(K)# K061274 OF 'LIKE DEVICE' WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF CERVICAL MYELOPATHY INVOLVED IN ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) ON ONE INTERVERTEBRAL DISC. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SCREW STRIPPED. SO, THE SCREW WAS REPLACED WITH A NEW ONE. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT DRIVER WAS SLIPPED AND STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099979 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG G9791223 H5665063

    Patients

    Seq Age Sex Outcome Treatment
    1 Female