BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC CL17X14MM H5MM - PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 18239962 · Received November 29, 2023

    Report

    Report Number
    MW5148603
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    October 25, 2023
    Report Date
    July 31, 2024
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    MJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 I HAD A SURGERY TO REPLACE MY C5-C6 CERVICAL DISC WITH AN ARTIFICIAL DISC (PRODISC-C) THAT WAS SOURCED FROM CENTINEL SPINE. AFTER EXPERIENCING ISSUES SWALLOWING AND HAVING FELT LIKE SOMETHING WAS LODGED IN MY THROAT FOR A COUPLE WEEKS, I WENT IN FOR X-RAYS ON (B)(6) 2023 TO DISCOVER THE ARTIFICIAL DISC HAD BEEN 90-95% DISLODGED FROM ITS POSITION. I WAS THEN ADMITTED TO THE HOSPITAL THAT EVENING OF (B)(6) 2023 FOR 24 HOUR MEDICAL SUPERVISION TILL THE ARTIFICIAL DISC COULD BE SURGICALLY REMOVED. THE DISC WAS REMOVED ON (B)(6) 2023 AND REPLACED WITH THE ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) FUSION METHOD TO FIX THE ISSUE. FOR MORE SPECIFIC MEDICAL RECORDS PLEASE CONTACT ME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01-AUG-2024 FOR MW5148603. AFTER REVIEWING THE MAUDE ADVERSE EVENT REPORT THAT WAS SUBMITTED BY CENTINEL SPINE LLC, THERE WERE MANY DISCREPANCIES IN THE MANUFACTURER NARRATIVE. I WOULD LIKE TO CLARIFY SOME FACTS CONCERNING WHEN THE REVISION ACDF(ANTERIOR CERVICAL DISCECTOMY AND FUSION) SURGERY, THE SUCCESSFULNESS PERCENTAGE OF THE SURGERY AFTER THE SURGICAL TRAUMA FROM THE MIGRATION OF THE DEFECTIVE PRODISC C ARTIFICIAL DISC, DETAILS ABOUT THE PHYSICAL DISC THAT WAS REMOVED, AND INVESTIGATION ACTIONS THAT WERE NEVER TAKEN BY CENTENIAL SPINE. THE REVISION SURGERY WAS DONE ON (B)(6) 2023 AND NOT (B)(6) 2023. ACCORDING TO MY NEW DOCTOR (NAME UPON REQUEST) DUE TO THE LEVEL OF SCAR TISSUE FROM THE MIGRATION TRAUMA THE REVISION SURGERY HAD A VARY LOW TO NO CHANCE OF SUCCESSFUL FUSION. IT'S OFFICIAL THAT THE RESULT OF THE REVISION SURGERY IS A FAILED FUSION WITH CONTINUED LINGERING PAIN EFFECTING MY EVERYDAY ACTIVITIES. FURTHERMORE, CENTINEL SPINE NEVER ASKED THE DOCTOR OR PATIENT FOR THE PHYSICAL MIGRATED ARTIFICIAL DISC TO BE RETURNED FOR ANY TYPE OF INSPECTION OR INVESTIGATION. CENTENIAL SPINE JUST USED GENERIC VERBAGE STATING THAT THE INCIDENT WAS WITHIN THE ALLOWED ADVERSE EFFECT ALLOWED PERCENTAGE WITHOUT ANY INVESTIGATION OR EXPLORATION OF WHY THE DEVICE CATASTROPHICALLY FAILED TO OPERATE AS INTENDED. ACCORDING TO DR. (B)(6) THE DEVICE WAS BROKEN IN HALF UPON REMOVAL DURING THE REVISION SURGERY. THAT FACT SHOULD WARRANT ACCOUNTABILITY BY CENTINEL SPINE LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430421 PRODISC CL17X14MM H5MM - PROSTHESIS INTERVERTEBRAL DISC PROSTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE, LLC. 09.820.045S

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Hospitalization| O| L DAILY MEN'S MULTI-VITAMIN.