BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATES

    MDR report key: 10463055 · Received August 27, 2020

    Report

    Report Number
    1526439-2020-01547
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    October 17, 2019
    Report Date
    August 4, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM./UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SIK HAM J., ET AL (2019) PROGRESSION OF OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT AFTER CERVICAL TOTAL DISC REPLACEMENT, KOREAN JOURNAL OF NEUROTRAUMA. VOLUME 15(2), PAGES 135-142 (KOREA, SOUTH) HTTPS://DOI.ORG/10.13004/KJNT.2019.15.E28 THIS RETROSPECTIVE STUDY AIMS TO ASSESS THE DEGREE OF OPLL PROGRESSION AFTER CERVICAL TDR AND TO UNDERSTAND THE TENDENCY FOR OPLL PROGRESSION TO BE SEEN UNDER CERTAIN CONDITIONS. FROM SEPTEMBER 2009 THROUGH NOVEMBER 2016, A TOTAL OF 33 PATIENTS WHO RECEIVED CERVICAL TDR ALONE OR WITH ANTERIOR CERVICAL FUSION SURGERY WERE REVIEWED. A TOTAL OF 22 PATIENTS ,ALL PATIENTS WERE MALE AND MILITARY SOLDIERS,MEAN AGE OF ALL PATIENTS WAS 40.7 YEARS (RANGE, 31¿52 YEARS), WERE ENROLLED IN THE STUDY. CERVICAL DISC PROSTHESIS WAS IMPLANTED INTO INTERVERTEBRAL SPACE. A SINGLE CASE OF BRYAN DISC (MEDTRONIC SOFAMOR DANEK USA INC., MEMPHIS, TN, USA), 15 CASES OF ACTIVC INTERVERTEBRAL DISC PROSTHESIS (B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY), A SINGLE CASE OF BAGUERA C CERVICAL PROSTHESIS (SPINEART SA, GENEVA, SWITZERLAND) AND 5 CASES OF THE PRODISC C (CENTINEL SPINE INC., WEST CHESTER, PA, USA) WERE USED. IN 15 PATIENTS WITH ADJACENT SEGMENT FUSION, A POLYETHERETHERKETONE CAGE FILLED WITH AN ALLOGRAFT CANCELLOUS BONE CHIP FOR FUSION, WAS INSERTED INTO THE DISC SPACE, AND FIXED WITH A PLATE AND SCREWS (SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, DEPUY SYNTHES, RAYNHAM, MA, USA).TDR-ONLY WAS USED IN 7 CASES, AND THE HYBRID SURGERY (TDR+ACDF) WAS USED IN 15 CASES. THE MEAN FOLLOW-UP PERIOD FROM THE SURGERY WAS 41.4 MONTHS (RANGE, 12¿114 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: FIGURE 3. IMMEDIATE POSTOPERATIVE SAGITTAL AND AXIAL COMPUTED TOMOGRAPHY IMAGES OF A (B)(6)-YEAR-OLD MALE UNDERWENT A TOTAL DISC REPLACEMENT AT C5-C6 . AFTER 61 MONTHS POSTOPERATIVELY, THE OPLL MASSES PROGRESSED. OPLL: OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. FIGURE 2. SAGITTAL PLANE OF PREOPERATIVE CERVICAL SPINE CT SCAN: THREE PATIENTS HAD THE CERVICAL DISC HERNIATION AND MINIMAL SEGMENTAL-TYPE OPLL. THEY SHOWED THE PROGRESSION OF THE OPLL AT THE LATEST CT SCAN AFTER TDR SURGERY. 9 CASES OF PROGRESSION OF OPLL IN PATIENTS WITH PRE-EXISTING OPLL. IN 11 CASES SHOWING THE PROGRESSION OF THE OPLL, THE MEAN SIZE OF OPLL PROGRESSION WAS 4.16 MM (RANGE, 0.34¿18.87 MM) IN THE LONGITUDINAL AXIS AND 1.57 MM (RANGE, 0.54¿3.91 MM) IN HORIZONTAL AXIS. ACCORDING TO THE DIRECTION OF THE PROGRESSION OF THE OPLL MASS, TWO CASES SHOWED PROGRESSION TO THE ACDF LEVEL, 6 CASES TO THE TDR LEVEL, AND 4 CASES TO THE ADJACENT LEVEL WHERE NO OPERATION WAS PERFORMED. OPLL PROGRESSION (N=12) ONE PATIENT UNDERWENT ADDITIONAL FUSION SURGERY DUE TO ADJACENT SEGMENT DISEASE. ONE PATIENT UNDERWENT REOPERATION DUE TO IMPLANT MIGRATION. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE SKYLINE ANTERIOR CERVICAL PLATE. IT CAPTURES A CASE OF A (B)(6)-YEAR-OLD MALE WHO HAD POSTOPERATIVE OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927388 UNKNOWN PLATES PLATE, FIXATION, BONE HRS MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention