BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2530088-2013-00230

    MDR report key: 3091359 · Received May 3, 2013

    Report

    Report Number
    2530088-2013-00230
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION RECEIVED FROM QUESTIONNAIRE, DATE OF EVENT: (B)(6) 2013. IMPLANTED: FROM (B)(6) 2011 TO (B)(6) 2010. CONCOMITANT PRODUCT: 2 NON-SYNTHES PEDICLE SCREWS MFR UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE RECEIVED BY MANUFACTURE 9/16/2013. THE PRODUCT DEVELOPMENT EVENT EVALUATION WAS COMPLETED WITHOUT THE RETURN OF THE DEVICE. CONCLUSION IS THIS EVALUATION IS IN REGARDS TO THE CONTINUED PAIN RESULTING FROM THE PRODISC-L DEVICE PRIOR TO PEDICAL SCREW FAILURE. UNRELIEVED PAIN IS AN INHERENT RISK WITH BOTH FUSION AND NON-FUSION DEVICES, AND IS OFTEN RELATED TO PROPER PATIENT SELECTION. BACK AND LOWER EXTREMITY PAIN EITHER SINGULARLY OR IN COMBINATION IS CURRENTLY LISTED IN THE SUMMARY OF SAFETY AND EFFECTIVENESS FOR PRO-DISC L, AND THE OVERALL RATE OF OCCURRENCE REPORTED IS CONSISTENT WITH THE CLINICAL HISTORY TO DATE. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE CONTINUED PAIN.

    Description of Event or Problem · 1

    PATIENT PRESENTED LOWER LEFT LEG PAIN, LOW BACK PAIN AND INSTABILITY AND THE PRODISC LUMBAR WAS IMPLANTED ON (B)(6) 2010. POST OPERATIVELY THE PATIENT STILL PRESENTED THE SAME PAIN AND INSTABILITY, THE SURGEON ADDED COMPETITOR POSTERIOR PEDICLE SCREWS, IMPLANT DATE UNKNOWN. THE PAIN AND INSTABILITY TEMPORARILY SUBSIDED. X-RAY FILMS TAKEN ON AN UNKNOWN DATE SHOWED THAT THE TWO PEDICLE SCREWS HAD BROKEN SO A REVISION WAS NEEDED. THE SURGEON DECIDED NOT TO REMOVE THE PRODISC LUMBAR ANTERIORLY BUT FOR CLINICAL REASONS REMOVED THE IMPLANT LATERALLY RATHER THAN ANTERIORLY, WHICH MADE IT DIFFICULT TO EXTRACT THE POLY INLAY. A HEMI-CORPECTOMY WAS PERFORMED TO REMOVE THE IMPLANT. AN EXPANDABLE CAGE WAS PLACED AND TWO DAYS LATER WAS BACKED UP WITH 2 POSTERIOR PEDICLE SCREWS. THIS IS REPORT NUMBER 1 OF 3 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194291 MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention 2 NON-SYNTHES PEDICLE SCREWS MFR UNKNOWN