BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4847488 · Received June 16, 2015

    Report

    Report Number
    2520274-2015-14431
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    March 15, 2008
    Report Date
    June 2, 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. THIS REPORT IS FOR UNKNOWN PRODISL SUPERIOR ENDPLATE IMPLANT, UNKNOWN QUANTITY, UNKNOWN ITEM NUMBER AND UNKNOWN LOT NUMBER. UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (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; WIRBELSÄULENCHIRURGIE, A (2008) ¿REVISION SURGERY AFTER IMPLANTATION OF A VERTEBRAL DISC PROSTHESIS¿; ORTHOPADE. 2008 - 37:339-346. DOI 10.1007/S00132-008-1229-1 SPRINGER MEDIZIN VERLAG 2008 (EU GERMANY ARTICLE). THIS ABSTRACT ARTICLE REPORTS ON THE ASSESSMENT OF THE REVISABILITY OF SURGERY AFTER THE ENDOPROSTHETIC REPLACEMENT OF VERTEBRAL DISCS SHOWS THAT THE SURGICAL APPROACH DEPENDS ON THE TIME OF REVISION SURGERY AND THE REASON WHY IT IS CARRIED OUT. EXPERIENCE IS BASED ON NINE REVISION OPERATIONS OUT OF 152 CERVICAL VERTEBRA PROSTHESES OF THE BRYAN AND PRODISC C TYPES IMPLANTED FROM 2003 TO 2007 AND 312 ENDOPROSTHESES OF THE CHARITÉ AND PRODISC TYPES IMPLANTED FROM 1999 TO 2007. RESULTS SHOW DIFFERING APPROACHES IN PERIOPERATIVE OR LATE POSTOPERATIVE REVISION OPERATIONS. OPERATIONS TO EXCHANGE IMPLANTS WERE NOT POSSIBLE, WHEREAS A CHANGE OF SURGICAL PROCEDURE IS THE RULE. THE SAME ACCESS ROUTE CAN USUALLY BE SELECTED IN THE CERVICAL SPINE, BUT IN THE LUMBAR SPINE THIS CAN ONLY BE DONE PERIOPERATIVELY; IF REVISION SURGERY IS CARRIED OUT AT A LATER DATE, AN ALTERNATIVE ACCESS ROUTE MUST BE USED. USING STRICT INDICATIONS FOR THE PRIMARY IMPLANT IS THE ONLY WAY TO PREVENT POSTOPERATIVE REVISION SURGERY THAT IS DUE TO AN INACCURATE PRIMARY ASSESSMENT AND NOT TO THE VERTEBRAL ENDOPROSTHESIS. THE NEXT GENERATION OF VERTEBRAL DISC ENDOPROSTHESES MUST INCORPORATE REDUCED LOAD OF THE ZYGAPOPHYSEAL JOINTS AND IMPROVED REVISABILITY COMPLICATIONS FROM THIS ARTICLE INCLUDE (9) REVISION OPERATIONS OUT OF 464 PATIENTS HAVING CERVICAL PROSTHESES FROM 1999 TO 2007, WITH COMPETITORS PRODUCT AND SYNTHES PRODISC C IMPLANTS. THIS REPORTED COMPLICATION IS FOR ONE UNKNOWN PATIENT WITH IMPLANT SUBSIDENCE. NO REVISION SURGERY. ALSO, TWO PATIENTS WITH REVISION SURGERY DUE TO SUBSIDENCE. THIS IS REPORT 7 OF 12 ITEMS FOR COMPLAINT (B)(4). UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THIS UNKNOWN ITEM IS FOR A PRO DISC L IMPLANT, SUPERIOR ENDPLATE ITEM AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389879 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention