BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE

    MDR report key: 5819084 · Received July 25, 2016

    Report

    Report Number
    2530088-2016-10199
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    June 24, 2016
    Report Date
    June 28, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION: AN EVENT DATE FOR POST-OPERATIVE PAIN IS NORMALLY LEFT UNKNOWN; HOWEVER, THE PATIENT IN THIS INSTANCE WAS VERY SPECIFIC AS TO WHEN THE PAIN FIRST BEGAN. AS SUCH, (B)(6) 2016 WILL BE LEFT AS THE DATE OF EVENT FOR THIS COMPLAINT. (B)(4) USED TO CAPTURE THE REPORTED DEEP VEIN THROMBOSIS (DVT). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. IT WAS REPORTED THE PATIENT EXPIRED LESS THAN 24 HOURS AFTER THE REVISION SURGERY; THE PATIENT EITHER EXPIRED ON (B)(6) 2016. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED: PART PDL-L-PT10S, LOT 9874934: MANUFACTURE DATE: SEPTEMBER 24, 2015. EXPIRATION DATE: AUGUST 31, 2018. (B)(4). NO MANUFACTURING DISCREPANCIES WERE NOTED THAT WOULD BE RELEVANT TO THE COMPLAINT DESCRIPTION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 WHICH WAS 72 HOURS AFTER A L4/5-L5/S1 TOTAL DISC REPLACEMENT PERFORMED, A PATIENT WAS CLIMBING STAIRS AND FELT A CRUNCH AND PAIN IN LOW BACK. THE PATIENT THEN UNDERWENT AN ANTERIOR REMOVAL OF PRODISC-L WITH REVISION TO A NON-SYNTHES DEVICE ON (B)(6) 2016. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2016. REPORTEDLY, THE PATIENT HAD AN ENLARGED VERTEBRAE ANTERIOR TO POSTERIOR LEAVING THE IMPLANTS LESS THAN DESIRABLE IN REGARDS TO SURFACE AREA COVERAGE. THE ANTERIOR PORTION OF THE IMPLANT DID NOT SIT ON THE ANTERIOR APOPHYSEAL RING. THE ORIGINAL SURGERY WAS CONSIDERED SUCCESSFULLY COMPLETED. HOWEVER, IT WAS NOTED THE USE OF THE PRODUCT WAS OFF LABEL; AS PER THE TECHNIQUE GUIDE FOR THIS DEVICE, PRODISC-L IS INDICATED AT ONE LEVEL OF THE SPINE. FOLLOWING THE SURGERY THE PATIENT WAS STABLE. THE PATIENT DID NOT HAVE PROLONGED BED REST AFTER SURGERY AND WAS WALKING THE NEXT DAY. ANTICOAGULANTS WERE USED POST-OPERATIVELY ONLY. DURING THE REVISION THERE WAS NO PRESENCE OF DAMAGE OR BREAKAGE TO THE INITIALLY IMPLANTED DEVICES. THE REVISION WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY TO EITHER THE ORIGINAL OR REVISION SURGERIES. OTHER MEDICAL INTERVENTION WAS ORDERED AFTER THE REVISION DUE TO SUSPECTED DEEP VEIN THROMBOSIS (DVT) IN THE LOWER EXTREMITY (STAT DIAGNOSTICS WERE ORDERED). THE PATIENT BEGAN EXPERIENCING PROBLEMS IN THE POST-ANESTHESIA CARE UNIT AFTER THE REVISION SURGERY. THE PATIENT EXPIRED LESS THAN 24 HOURS AFTER THE REVISION DUE TO AN EMBOLISM. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472703 POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE 9874934

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention