BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

    MDR report key: 5233017 · Received November 18, 2015

    Report

    Report Number
    2520274-2015-17198
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    January 25, 2015
    Report Date
    October 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN SYNFIX-LR PEEK CAGES WITH AN UNKNOWN PART NUMBER AND LOT NUMBERS. DEVICE PRODUCT CODE: OVD. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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 JOURNAL ARTICLE: NI, J., ET AL (2015). RADIOLOGICAL EVALUATION OF ANTERIOR LUMBAR FUSION USING PEEK CAGES WITH ADJACENT VERTEBRAL AUTOGRAFT IN SPINAL DEFORMITY LONG FUSION SURGERIES. EUR SPINE J 24: 791-799. CHINA AND USA. THE OBJECTIVE OF THIS RETROSPECTIVE RADIOGRAPHY STUDY WAS TO EVALUATE THE RADIOGRAPHIC CHARACTERISTICS OF POLYETHERETHERKETONE (PEEK) CAGES PACKED WITH ADJACENT VERTEBRAL AUTOGRAFT MATERIAL IN LUMBAR ANTERIOR LUMBAR INTERBODY FUSION (ALIF) IN SPINAL DEFORMITY LONG FUSION SURGERIES. FROM (B)(6) 2008 TO (B)(6) 2012, 40 PATIENTS (5 MALES AND 35 FEMALES, AGE RANGE 49-79 YEARS) WITH CORONAL AND/OR SAGITTAL SPINE DEFORMITIES UNDERWENT STAGED CORRECTIVE SURGERY COMBINED WITH LUMBAR ALIF USING PEEK CAGES AT L3-L4, L4-L5, OR L5-S1 SEGMENT WITH POSTERIOR LONG INSTRUMENTATION. AN ANTERIOR RETROPERITONEAL APPROACH WAS USED FOR ALIF DURING THE FIRST STAGE OF A TWO-STAGE PROCEDURE. PATIENTS UNDERWENT POSTERIOR FUSION TO THE SACRUM OR ILIUM USING PEDICLE SCREW SYSTEMS DURING THE SECOND STAGE OF SURGERY. EACH DONOR VERTEBRA WAS PACKED WITH CORTICOCANCELLOUS ALLOGRAFT FROM THE SYNTHES CORPORATION. TWELVE SYNFIX-LR PEEK CAGES (SYNTHES) WERE IMPLANTED IN 7 PATIENTS. TWO OTHER PEEK MANUFACTURERS WERE IMPLANTED IN THE REMAINING PATIENTS. UPRIGHT STANDARD LATERAL DIGITAL RADIOGRAPHIES WERE MEASURED AT DIFFERENT INTERVALS. THE STUDY EXAMINED THE INTERBODY FUSION RATE AND CAGE SUBSIDENCE AT 3 MONTHS POSTOPERATIVELY AND FINAL FOLLOW-UP. THE MEAN FOLLOW-UP TIME WAS 27.5 MONTHS (13-49 MONTHS). THE DISTANCE OF CAGE MIGRATION AT FINAL FOLLOW-UP AND THE IMPROVEMENT IN LUMBAR LORDOSIS WERE EVALUATED. THE RATE OF "COLLAPSE" OF THE ADJACENT VERTEBRA WHERE THE AUTOGRAFT WAS HARVESTED WAS ASSESSED AT THE FINAL FOLLOW-UP. THE CAGE-RELATED POSTEROPERATIVE COMPLICATIONS IN THIS SERIES WERE ALSO ANALYZED. COMPLICATIONS: ONE PATIENT (UNKNOWN SPECIFICS) UNDERWENT REVISION SURGERY BECAUSE THE PROXIMAL HOOKS HAD DISLODGED FROM THEIR FIXATION POINTS. THIS MOVEMENT CAUSED THE RODS AND THE HOOKS TO DISPLAY PROMINENCE. HOOKS AND RODS MANUFACTURERS ARE UNKNOWN. 18 MONTHS POSTOPERATIVE LATERAL RADIOGRAPH SHOWED NON-UNION AT L4-L5. PATIENT SPECIFICS WERE NOT PROVIDED. RADIOGRAPH INCLUDED. FUSION RATE AT FINAL FOLLOW UP WAS 96.4% (81/84). THIS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SYNFIX-LR PEEK CAGES WITH AN UNKNOWN PART NUMBER AND LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764562 INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR MAX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention