BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4781243 · Received May 19, 2015

    Report

    Report Number
    2530088-2015-10335
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SHIM C., LEE S., MAENG D., LEE S-H. (2005) VERTICAL SPLIT FRACTURE OF THE VERTEBRAL BODY FOLLOWING TOTAL DISC REPLACEMENT USING PRODISC: REPORT OF TWO CASES. J SPINAL DISORD TECH,18: 465¿469. KOREA. THIS REPORT IS FOR UNKNOWN PRODISC-L, INFERIOR ENDPLATE/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(6). (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE; SHIM C., LEE S., MAENG D., LEE S-H. (2005) VERTICAL SPLIT FRACTURE OF THE VERTEBRAL BODY FOLLOWING TOTAL DISC REPLACEMENT USING PRODISC: REPORT OF TWO CASES. J SPINAL DISORD TECH,18: 465¿469. KOREA. THE AUTHORS REPORT TWO CASES OF VERTICAL SPLIT FRACTURE OF THE VERTEBRAL BODY AFTER TOTAL DISC REPLACEMENT (TDR) WITH PRODISC AND DISCUSS THE ISSUE OF THE HEIGHT OF THE KEEL OF THE PROSTHESIS. CASE 2: A (B)(6) HAD HAD LOW BACK PAIN FOR 10 YEARS. SHE COULD NOT BEND FORWARD WITHOUT ASSISTANCE AND COULD NOT SIT ON THE FLOOR OR A CHAIR FOR MORE THAN A FEW MINUTES. HER SLEEP WAS DISTURBED OWING TO THE BACK PAIN. ON MRI AND RADIOGRAPHY, SEVERE DEGENERATION WITH SPACE NARROWING OF THE L4¿L5 DISC SPACE WAS SEEN, AND THE DISC WAS REPLACED WITH A PRODISC. THE SURGERY WAS DONE IN THE USUAL WAY, BUT THE BONE BLEEDING AFTER CHISELING WAS HEAVIER THAN NORMALLY SEEN. THE SURGEON DID NOT NOTICE THE FRACTURE, EVEN THOUGH THE COPIOUS BONE BLEEDING OCCURRED. THE ESTIMATED TOTAL BLOOD LOSS WAS 550 ML. VERTICAL FRACTURES OF THE L4 AND L5 VERTEBRAL BODIES WERE NOTICED IN A POSTOPERATIVE CT SCAN. THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED ON THE SIXTH POSTOPERATIVE DAY. AT 3-MONTH FOLLOW-UP, HER SLEEP WAS NO LONGER ADVERSELY AFFECTED BY THE PAIN, BUT SHE STILL COMPLAINED OF BACK PAIN WHEN SITTING. SHE IS DISSATISFIED WITH THE SURGERY BECAUSE OF THE PERSISTENT BACK PAIN, DESPITE THE FACT THAT SHE CAN NOW SLEEP WELL. THIS IS REPORT 6 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-L, INFERIOR ENDPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325194 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention