BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTIGRAFT

    MDR report key: 3579169 · Received January 16, 2014

    Report

    Report Number
    2032282-2014-00006
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    October 28, 2013
    Report Date
    January 8, 2014
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LACK OF INFORMATION, THE CASE IS NOT CURRENTLY ASSESSABLE AND THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED AND THE CASE WAS RE-ASSESSED: BAXTER MEDICAL ASSESSMENT: SACROILIITIS OCCURRING 12 MONTHS AFTER LUMBAR SPINE SURGERY IS NOT RELATED TO THE IMPLANTATION OF A BONE GRAFT SUBSTITUTE, BUT TO THE DEGENERATIVE, CHRONIC DISEASE OF THE SPINAL COLUMN, FOR WHICH PATIENT HAD TO UNDERGO SURGERY. AS THE EVENT WAS DETERMINED TO NOT BE RELATED TO THE USE OF INDUCTIGRAFT, NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    PLEASE KNOW THAT INDUCTIGRAFT IS NOT REGISTERED IN THE US. IT HAS SIMILAR COMPOSITION TO ACTIFUSE BONE GRAFT SUBSTITUTE (K081979). THE FOLLOWING IS A REPORT FROM A STUDY ((B)(4)), A PROSPECTIVE OPEN-LABEL NON-RANDOMIZED (B)(4) CLINICAL STUDY TO EVALUATE THE PERFORMANCE OF INDUCTIGRAFT. PROTOCOL#: (B)(4); THE REPORT REFERS TO SUBJECT ((B)(6)), A FEMALE (B)(6) YEARS OLD, AND HEIGHT: 164 CM. SITE REPORTED AE-TERM: SACROILIITIS ON RIGHT SIDE; ACTION TAKEN: CT ASSISTED SACROILIACAL JOINT BLOCADE; ONSET OF FIRST SIGNS/SYMPTOMS OF AE: (B)(6) 2013 AT 8:00 AM; ADMISSION DATE: (B)(6) 2013; DISCHARGE DATE: (B)(6) 2013; DATE OF OPERATION: (B)(6) 2012; TRIAL DEVICE EXPIRY DATE: JAN 2014; LOT NUMBER: ELN83F1117HP, EVENT DESCRIPTION: THE PATIENT¿S NEW COMPLAINTS STARTED IN (B)(6) 2013 WITH RIGHT SACROILIACAL PAIN WITHOUT NEUROLOGICAL DEFICIT. THE CT ((B)(6) 2013) DID NOT PROVE ANY PATHOLOGICAL DIFFERENCE. FOLLOW-UP INFORMATION RECEIVED ON 09-JAN-2014: GAVE THE PATIENT A CT ASSISTED SACROILIACAL JOINT BLOCADE IN BOTH SIDES, AND SHE GOT 5 NEODOLPASSE INFUSION. THE PATIENT LEFT THE HOSPITAL WITH MINIMAL RESIDUAL PAIN. CAUSALITY ASSESSMENT: NOT RELATED TO DEVICE AND UNLIKELY RELATED TO PROCEDURE; SITE REPORTED SERIOUSNESS CRITERIA: INVOLVED OR PROLONGED HOSPITALIZATION; SITE REPORTED SEVERITY: MILD; PATIENT OUTCOME: RESOLVED WITH RESIDUAL SIGNS OR SYMPTOMS ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 FROM CSTL: INDICATION FOR USE OF INDUCTIGRAFT. - SPINE FUSION (GRAFT MATERIAL). ANATOMICAL LOCATION OF THE IMPLANT. - SPINE. VOLUME OF PRODUCT USED. - 40 ML. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014: LABORATORY PARAMETERS DURING RE-ADMISSION WITH SPECIAL EMPHASIZE OF INFLAMMATORY/INFECTION PARAMETERS. - THE PATIENT HAD ONLY SLIGHTLY ELEVATED SEDIMENTATION (16MM/H) IN HER LAB MADE IN SEPTEMBER 2013. THE SACROILIAC JOINT AS PAIN SOURCE WAS IDENTIFIED WITH THE POSITIVE PROVOCATION TESTS AND THE LOCAL ANALGESIC BLOCKADE. BASED ON THESE, NO SPECIFIC CONDITION (ANTIMMUN, INFECTIOUS, ETC) IS EXPECTED BEHIND THE PAIN. FURTHER EXAMINATIONS (LAB, MRI) WILL BE INDICATED IF THE PAIN RETURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42085 INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD ELN83F1117HP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other