BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

    MDR report key: 5112020 · Received September 29, 2015

    Report

    Report Number
    2520274-2015-15902
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    ODP
    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. YAMAGATA ET AL (2012) OUTCOMES OF CONTEMPORARY USE OF RECTANGULAR TITANIUM STAND-ALONE CAGES IN ANTERIOR CERVICAL DISCECTOMY AND FUSION: CAGE SUBSIDENCE AND CERVICAL ALIGNMENT. JOURNAL OF CLINICAL NEUROSCIENCE 19: 1673- 1678. THIS REPORT IS FOR UNKNOWN SYNTHES TITANIUM CAGE (4.5 MM, 5.5 MM, 6.5 MM AND 7.5 MM)/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(6). (B)(4). HEALING IMPAIRED FOR NON-UNION. 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; YAMAGATA ET AL (2012) OUTCOMES OF CONTEMPORARY USE OF RECTANGULAR TITANIUM STAND-ALONE CAGES IN ANTERIOR CERVICAL DISCECTOMY AND FUSION: CAGE SUBSIDENCE AND CERVICAL ALIGNMENT. JOURNAL OF CLINICAL NEUROSCIENCE 19: 1673-1678. BETWEEN 2006 AND 2010, THE PERFORMED CERVICAL SPINE SURGERY (BOTH ANTERIOR AND POSTERIOR) ON 194 PATIENTS, THE ANTERIOR PROCEDURE WAS PERFORMED FOR 123 PATIENTS AND THE POSTERIOR PROCEDURE WAS PERFORMED FOR 71 PATIENTS. THIS RETROSPECTIVE STUDY INCLUDED 47 CONSECUTIVE PATIENTS (31 MALES AND 16 FEMALES, MEAN AGE: 60.7 YEARS) WHO UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). 63 RECTANGULAR TITANIUM CAGES (SYNTHES) WERE IMPLANTED DURING 31 1-LEVEL AND 16 2-LEVEL PROCEDURES. A 4.5 MM CAGE WAS USED IN 29 CASES, A 5.5 MM CAGE IN 26, A 6.5 MM CAGE IN SIX AND A 7.5 MM CAGE IN TWO. NO INSTANCES OF CAGE DISPLACEMENT OR EXTRUSION WERE ENCOUNTERED. NONE OF THE PATIENTS DEVELOPED SURGERY-RELATED COMPLICATIONS (E.G. SURGICAL SITE INFECTION, HORNER SYNDROME, DYSPNEA OR DYSPHAGIA). MEAN NEUROSURGICAL CERVICAL SPINE SCALE SCORES WERE SIGNIFICANTLY IMPROVED AT 1 YEAR AFTER SURGERY. COMPLICATIONS REPORTED: TWELVE OF 63 INSERTED CAGES WERE FOUND TO HAVE GRADE 2 OR 3 SUBSIDENCE, OCCURRING IN 11 OF 47 PATIENTS (EIGHT MALES AND THREE FEMALES). NO OSSEOUS FUSION EVIDENT IN 7 UNIDENTIFIED PATIENTS 1 YEAR AFTER SURGERY. THIS REPORT REFERS TO NONUNION EVIDENT IN 7 UNIDENTIFIED PATIENTS 1 YEAR AFTER SURGERY. THIS IS REPORT 12 OF 12 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM CAGE (4.5 MM, 5.5 MM, 6.5 MM AND 7.5 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641194 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention