BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

    MDR report key: 4398822 · Received January 8, 2015

    Report

    Report Number
    2520274-2015-10055
    Event Type
    Injury
    Date Received
    January 8, 2015
    Date of Event
    August 19, 2013
    Report Date
    December 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE ; BEHRBALK ET AL (19 AUGUST 2013) FUSION AND SUBSIDENCE RATE OF STAND ALONE ANTERIOR LUMBAR INTERBODY FUSION USING PEEK CAGE WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2. EUR SPINE JOURNAL 22:2869¿2875. THIS STUDY ASSESSED THE FUSION AND SUBSIDENCE RATES OF STAND-ALONE ANTERIOR LUMBAR INTERBODY FUSION (ALIF) USING THE SYNFIX-LR INTERBODY CAGE WITH 6 ML/LEVEL OF BONE MORPHOGENETIC PROTEIN-2 (BMP-2). THIRTY-TWO ALIF PROCEDURES WERE PERFORMED BY A SINGLE SURGEON IN 25 PATIENTS. THE AVERAGE AGE OF THE STUDY GROUP WAS 52 ± 14 YEARS (RANGE 23¿71 YEARS). THE STUDY GROUP INCLUDED 18 FEMALES AND 7 MALES. TWENTY-FIVE PROCEDURES WERE PERFORMED FOR SYMPTOMATIC DISK DEGENERATION (SDD) WITHOUT SPONDYLOLISTHESIS (SDD GROUP) AND SEVEN PROCEDURES WERE PERFORMED FOR SDD WITH GRADE-I OLISTHESIS (SDD-OLISTHESIS GROUP), GENDER DISTRIBUTION WAS SIMILAR IN BOTH GROUPS. A TOTAL OF 32 ALIF OPERATIONS WAS PERFORMED: THREE FUSIONS OF L3-4 LEVEL, 15 FUSIONS OF L4-5 LEVEL AND 14 FUSIONS OF L5-S1 LEVEL. THE AVERAGE POST-OPERATIVE FOLLOW-UP WAS 17 ± 6 MONTHS (RANGE 12¿31 MONTHS). SUBSIDENCE WAS OBSERVED IN 1 PROCEDURE IN THE SDD GROUP AND IN 4 PROCEDURES IN THE SDD-OLISTHESIS GROUP. TWO SUBSIDENCE CASES IN THE SDD-OLISTHESIS GROUP UNITED UNEVENTFULLY WITHIN 6 MONTHS. THE REMAINING TWO SUBSIDENCE CASES IN THE SDD-OLISTHESIS GROUP AND THE SINGLE SUBSIDENCE CASE IN THE SDD GROUP RESULTED IN SYMPTOMATIC NON-UNION AND REQUIRED REVISION SURGERY. UNION WAS ACHIEVED IN 24 OF 25 CASES IN THE SDD GROUP AND IN 5 OF 7 CASES IN THE SDD-OLISTHESIS GROUP. DUE TO THE SMALL SIZE OF THESE SUBGROUPS THE STUDY WAS UNDERPOWERED TO DETECT A DIFFERENCE IN FUSION RATES. THEREFORE, THE STATISTICAL DIFFERENCE BETWEEN THE GROUPS COULD NOT BE CLAIMED CONFIDENTLY. THE OVERALL FUSION RATE OF STAND-ALONE ALIF USING THE SYNFIX-LR SYSTEM WITH BMP-2 WAS 90.6 %, COMPARABLE WITH OTHER PUBLISHED SERIES. NO BMP-2 RELATED COMPLICATION OCCURRED AT A DOSE OF 6 MG/LEVEL. THE AUTHORS REPORTED THAT DEGENERATIVE SPONDYLOLISTHESIS AND OBESITY SEEMED TO INCREASE THE RATE OF IMPLANT SUBSIDENCE, AND THUS BELIEVED THAT ADDING POSTERIOR FUSION FOR THESE CASES SHOULD BE CONSIDERED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN SYNFIX-LR CAGE, UNKNOWN PART#/LOT#, UNKNOWN QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15376 INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention