BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTIGRAFT

    MDR report key: 2454844 · Received February 16, 2012

    Report

    Report Number
    2954761-2012-00005
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    December 31, 2011
    Report Date
    January 12, 2012
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS A SERIOUS ADVERSE EVENT REPORT FROM A PROSPECTIVE OPEN-LABEL NON-RANDOMIZED MULTI-CENTER CLINICAL STUDY TO EVALUATE THE PERFORMANCE OF INDUCTIGRAFT IN POSTEROLATERAL FUSION (APOLLO, STUDY IDENTIFIER: (B)(4)). APPARENTLY, THE (B)(6) FEMALE PATIENT EXPERIENCED FEVER AND ABDOMINAL PAIN FOLLOWING LUMBAR SPINAL SURGERY IN WHICH INDUCTIGRAFT HAS BEEN USED. THE SYMPTOMS OCCURRED ON DAY 2-7 POST SURGERY AND REQUIRED EXPLORATORY LAPAROSCOPY FOR SUSPICION OF APPENDICITIS THAT HAS NOT BEEN CONFIRMED. LABORATORY TESTING WAS INDICATIVE FOR AN INFLAMMATORY REACTION WITH NEGATIVE (EXTENSIVE) BACTERIOLOGY TESTING. THE CT SCAN WAS INDICATIVE FOR A RETROPERITONEAL SWELLING, WHICH MAY ALSO REFLECT AN INFLAMMATORY PROCESS ADJACENT TO THE SURGICAL AREA. THE INVESTIGATOR CONSIDERED THE EVENT NOT RELATED TO THE STUDY DEVICE, BUT PROBABLY RELATED TO THE STUDY PROCEDURE (LUMBAR SPINAL SURGERY). WE CANNOT FOLLOW THIS RATIONALE, SINCE THE STUDY MEDICAL DEVICE HAS BEEN IMPLANTED IN THE SAME AREA WHERE THE SURGICAL PROCEDURE HAS BEEN PERFORMED, AND BY THAT WE CANNOT EXCLUDE THAT THE INVESTIGATIONAL MEDICAL DEVICE HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER IN AN EFFORT TO RECEIVE LAB PARAMETERS AND THE IMAGING STUDIES (CT AND/OR MRI SCANS OF THE SURGICAL FIELD) BEFORE AND AFTER SURGERY IN ORDER TO COMPLETE THE EVALUATION OF THE COMPLAINT. NO RESPONSE WAS RECEIVED. THE MANUFACTURING FACILITY, BAXTER (B)(4), COMPLETED THE INVESTIGATION. A REVIEW OF THE BATCH RECORD FOR THIS PRODUCT LOT SHOWED THAT ALL RELEASE/TESTING SPECIFICATIONS WERE MET. THE REVIEW SHOWED NO NON-CONFORMITIES, FAILURES, REWORK, OR DEVIATIONS THAT WERE RELATED TO THE REPORTED COMPLAINT ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, THE INFORMATION WILL BE EVALUATED AND A FOLLOW-UP SUBMISSION WILL BE SENT. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    PLEASE KNOW THAT INDUCTIGRAFT IS NOT REGISTERED IN THE U.S. IT HAS SIMILAR COMPOSITION TO ACTIFUSE BONE GRAFT SUBSTITUTE (K081979). THE FOLLOWING IS A REPORT FROM STUDY ((B)(4)), (A PROSPECTIVE OPEN-LABEL NON-RANDOMISED MULTI-CENTRE CLINICAL STUDY TO EVALUATE THE PERFORMANCE OF INDUCTIGRAFT. THE REPORT WAS SENT BY A PHYSICIAN AND REFERS TO SUBJECT ((B)(6)), A FEMALE (B)(6). THE SUBJECT WHO HAD NO SPECIFIED MEDICAL HISTORY, EXPERIENCED PYREXIA AND RAISED WBC ON (B)(6) 2011, TWO DAYS AFTER UNDERGOING BACK SURGERY. THE REACTION WAS CONSIDERED TO BE SERIOUS BY THE REPORTER BECAUSE IT PROLONGED HOSPITALIZATION. THE SUBJECT WAS HOSPITALIZED FOR BACK SURGERY WITH INDUCTIGRAFT ON (B)(6) 2011. ON (B)(6) 2011 THE SUBJECT EXPERIENCED PYREXIA AND ABDOMINAL (RIF) PAIN. BLOOD TESTS ON (B)(6) 2011 SHOWED AN ELEVATED WHITE BLOOD COUNT OF 13.66 10*9/L (REFERENCE RANGE 4.2-10.8), ELEVATED NEUTROPHIL COUNT OF 12.02 10*9/L (REFERENCE RANGE 2.0-7.5), AND ELEVATED C REACTIVE PROTEIN LEVEL OF 212 MG/L (REFERENCE RANGE 0-10). A CT SHOWED SOME RETROPERITONEAL SWELLING, AND GAS SHADOWS WHICH THE INVESTIGATOR THOUGHT MIGHT BE DUE TO APPENDICITIS OR AN INFECTION. BLOOD CULTURES TAKEN ON (B)(6) 2011 WERE NEGATIVE FOR BOTH ANAEROBIC AND AEROBIC BACTERIA, AS WAS A CULTURE FROM THE EPIDURAL TIP, A FLOW CYTOMETRY TEST ON CATHETER URINE AND A WOUND SWAB. A LAPAROSCOPY HAD NEGATIVE FINDINGS. A SPUTUM TEST ON (B)(6) 2012 SHOWED NORMAL UPPER RESPIRATORY TRACT FLORA. THE PATIENT RECEIVED TREATMENT WITH IV FLUIDS AND ANTIBIOTICS (MEROPENEM AND CLINDAMYCIN). THE PATIENT WAS NOTED TO HAVE RECOVERED ON (B)(6) 2012. THE INVESTIGATOR CONSIDERED THE ADVERSE EVENT(S) TO BE UNLIKELY RELATED TO STUDY DEVICE BUT LIKELY RELATED TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD ELN83F0461HP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization ORAMORPHE ((B)(6) 2011 TO UNK) CODEINE ((B)(6)