BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 7241374 · Received February 5, 2018

    Report

    Report Number
    8030965-2018-50847
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    April 21, 2016
    Report Date
    January 15, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR 1 QUANTITY OF UNKNOWN CAGE/SPACERS /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI 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. THE MANUFACTURE DATE IS UNKNOWN. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: YAMAGATA ET AL (2017) A MINIMUM 2-YEAR COMPARATIVE STUDY OF AUTOLOGOUS CANCELLOUS BONE GRAFTING VERSUS BETA-TRICALCIUM PHOSPHATE IN ANTERIOR CERVICAL DISCECTOMY AND FUSION USING A RECTANGULAR TITANIUM STAND-ALONE CAGE. NEUROSURGICAL REVIEW, VOLUME 39, PAGE 475-482. CHINA THE PURPOSE OF THIS STUDY IS TO INVESTIGATE THE EFFICACY OF ¿-TRICALCIUM PHOSPHATE (¿-TCP) GRANULES AS A PACKING MATERIAL INSTEAD OF AUTOLOGOUS ILIAC BONE IN 1- OR 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) USING A RECTANGULAR TITANIUM STAND-ALONE CAGE. ALL PATIENTS PRESENTED WITH RADICULOPATHY AND/OR MYELOPATHY DUE TO DISC HERNIATION, OSTEOPHYTE FORMATION, OR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL) BEFORE SURGERY. THIS IS A RETROSPECTIVE REVIEW OF A STUDY THAT INCLUDED 100 PATIENTS WHO UNDERWENT ACDF USING RECTANGULAR TITANIUM STAND-ALONE CAGES (DEPUY SYNTHES, JOHNSON & JOHNSON, (B)(4)), WHERE 55 CONSECUTIVE PATIENTS HAD AUTOLOGOUS ILIAC CANCELLOUS BONE GRAFTING (AUTOGRAFT GROUP) FROM 2007 TO 2010 AND THE NEXT 45 CONSECUTIVE PATIENTS HAD ¿-TRICALCIUM PHOSPHATE AS PACKAGING MATERIAL (¿-TCP GROUP) FROM 2011 TO 2012. 72 RECTANGULAR TITANIUM CAGES WERE IMPLANTED FOR 38 SINGLE AND 17 TWO-LEVEL PROCEDURES IN THE AUTOGRAFT GROUP, AND 64 RECTANGULAR TITANIUM CAGES WERE IMPLANTED FOR 26 SINGLE AND 19 TWO-LEVEL PROCEDURES IN THE ¿-TCP GROUP. ALL PATIENTS WERE FOLLOWED PERIODICALLY FOR AT LEAST 2 YEARS AFTER SURGERY. THE POSTOPERATIVE FOLLOW-UP TIME RANGED FROM 24 TO 84 MONTHS (AVERAGE 51.2 MONTHS). AGE AT THE TIME OF SURGERY WAS 57.6± 12.0 YEARS IN THE AUTOGRAFT GROUP AND 57.5± 13.1 YEARS IN THE ¿-TCP GROUP. THERE WERE 35 FEMALE, 20 MALE IN THE AUTOGRAFT GROUP AND 28 FEMALE, 17 MALE IN THE ¿-TCP GROUP. POST-OPERATIVE EVALUATION INCLUDED CAGE SUBSIDENCE, C2¿7 ANGLE OF SPINAL CURVATURE, AND OSSEOUS BONY FUSION. CAGE SUBSIDENCE WAS EVALUATED AND CLASSIFIED INTO FOUR GRADES : GRADES 0 AND 1 WERE STRATIFIED INTO THE NON-SUBSIDED GROUP AND GRADES 2 AND 3 INTO THE SUBSIDED GROUP ¿ GRADE 0, NO SUBSIDENCE, GRADE 1, LESS THAN ONE-THIRD SUBSIDENCE, GRADE 2, LESS THAN TWO-THIRD SUBSIDENCE AND GRADE 3, MORE THAN TWO-THIRD SUBSIDENCE. OSSEOUS BONY FUSION WAS CLASSIFIED INTO THREE GRADES: OSSEOUS UNION, PARTIAL UNION, AND NONUNION. OSSEOUS UNION WAS DEFINED AS THE PRESENCE OF A COMPLETE BONY BRIDGE IN THE INTERVERTEBRAL SPACE AND COMPLETE STABILITY ON DYNAMIC FLEXION AND EXTENSION STUDIES. PARTIAL UNION WAS DEFINED AS THE ABSENCE OF A RADIOLOGICAL HALO AROUND THE CAGE AND PRESENCE OF A PARTIAL BONY BRIDGE IN THE INTERVERTEBRAL SPACE. NONUNION WAS DEFINED AS THE PRESENCE OF A RADIOLOGICAL HALO AROUND THE CAGE. OSSEOUS UNION AND PARTIAL UNION WERE RECOGNIZED AS CLINICALLY STABLE, AND NONUNION WAS RECOGNIZED AS PSEUDOARTHROSIS. THE FOLLOWING COMPLICATIONS WERE NOTED: 2 PATIENTS UNDERWENT SECOND REVISION SURGERY DURING THE FOLLOW-UP PERIOD. RADIOLOGICAL EVALUATION FINDINGS 1 YEAR AFTER SURGERY - AUTOGRAFT GROUP GRADE 0 OR 1 CAGE SUBSIDENCE WAS NOTED IN 60 OF 72 INSERTED CAGES IN THE AUTOGRAFT GROUP GRADE 2 OR 3 CAGE SUBSIDENCE WAS NOTED IN 12 OF 72 INSERTED CAGES IN THE AUTOGRAFT GROUP PARTIAL UNION WAS NOTED IN 47 OF 72 CAGES IN THE AUTOGRAFT GROUP NON-UNION WAS NOTED IN 13 OF 72 CAGES IN THE AUTOGRAFT GROUP RADIOLOGICAL EVALUATION FINDINGS 1 YEAR AFTER SURGERY - ¿-TCP GROUP GRADE 0 OR 1 CAGE SUBSIDENCE WAS NOTED IN 53 OF 64 INSERTED CAGES IN THE ¿-TCP GROUP GRADE 2 OR 3 CAGE SUBSIDENCE WAS NOTED IN 11 OF 64 INSERTED CAGES IN THE ¿-TCP GROUP PARTIAL UNION WAS NOTED IN 39 OF 64 CAGES IN THE ¿-TCP GROUP NON-UNION WAS NOTED IN 11 OF 64 CAGES IN THE ¿-TCP GROUP RADIOLOGICAL EVALUATION FINDINGS 2 YEARS AFTER SURGERY - AUTOGRAFT GROUP GRADE 0 OR 1 CAGE SUBSIDENCE WAS NOTED IN 58 OF 72 INSERTED CAGES IN THE AUTOGRAFT GROUP GRADE 2 OR 3 CAGE SUBSIDENCE WAS NOTED IN 14 OF 72 INSERTED CAGES IN THE AUTOGRAFT GROUP PARTIAL UNION WAS NOTED IN 25 OF 72 CAGES IN THE AUTOGRAFT GROUP RADIOLOGICAL EVALUATION FINDINGS 2 YEARS AFTER SURGERY - ¿-TCP GROUP GRADE 0 OR 1 CAGE SUBSIDENCE WAS NOTED IN 52 OF 64 INSERTED CAGES IN THE ¿-TCP GROUP GRADE 2 OR 3 CAGE SUBSIDENCE WAS NOTED IN 12 OF 64 INSERTED CAGES IN THE ¿-TCP GROUP PARTIAL UNION WAS NOTED IN 23 OF 64 CAGES IN THE ¿-TCP GROUP THIS REPORT IS FOR RECTANGULAR TITANIUM STAND-ALONE CAGES (DEPUY SYNTHES, JOHNSON & JOHNSON, (B)(4)) A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84286 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention