BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC L US

    MDR report key: 9849292 · Received March 18, 2020

    Report

    Report Number
    3007494564-2020-00015
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 18, 2020
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    MJO
    UDI-DI
    00843193111746
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECT MANUFACTURER FOR SYNTHES TO CENTINEL SPINE, LLC.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY THE REPORTER CONFIRMED THE INITIAL ASSESSMENT THAT THE PATIENT REQUIRED MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY. THE EXPULSION OF THE PE INLAY MAY HAVE BEEN CAUSING OR CONTRIBUTING TO THE PATIENT'S PAIN. IT WAS REPORTED THE PATIENT HAD OSTEOPENIA; HOWEVER, THERE WAS NO INDICATION IF THIS CAUSED OR CONTRIBUTED TO THE MIGRATION/EXPULSION OF THE PRODISC L INLAY. THE RISK ASSESSMENT IDENTIFIED 2 RISKS ASSOCIATED WITH INLAY EXPULSION. THERE WAS NO INDICATION OF NEW OR UNKNOWN RISKS BASED ON THE INFORMATION PROVIDED. REVIEW OF COMPLAINTS DETERMINED THE COMPLAINT RATE IS WITHIN ALLOWABLE LIMITS ESTABLISHED IN THE DFMEA. THERE ARE NO CAPAS ASSOCIATED WITH THIS COMPLAINT. REVIEW OF THE PICTURES AND X-RAYS PROVIDED CONFIRMED INLAY EXPULSION. THE INVESTIGATION COULD NOT DETERMINE A CAUSE FOR THIS ADVERSE EVENT. THE DEVICE WAS SUCCESSFULLY RETRIEVED AND ASSIGNED PDL-RD-002 BY THE THIRD PARTY LABORATORY. IF PERTINENT INFORMATION BECOMES AVAILABLE FROM THE RETRIEVAL TESTING, THIS REPORT MAY BE UPDATED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REPORTED TO HAVE LOW BACK PAIN WHICH WAS CAUSED OR CONTRIBUTED TO BY THE PATIENT'S PRODISC L US IMPLANT. IMAGING OF THE PRODISC L DEVICE FOUND THE PRODISC L PE INLAY HAD EXPELLED FROM THE INFERIOR ENDPLATE. SURGICAL INTERVENTION TO REMOVE THE PRODISC L IMPLANT WAS PERFORMED ON (B)(6) 2020. THE PATIENT WAS CONVERTED TO A FUSION VIA UNKNOWN DEVICE FROM L4 THROUGH S1. THE PRODISC L DEVICE WAS IMPLANTED AT L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314461 PRODISC L US PROSTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE, LLC. PDL-L-SP11S 6143417 00843193111746

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention