BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTIGRAFT

    MDR report key: 3112545 · Received May 14, 2013

    Report

    Report Number
    2032282-2013-00052
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT UNDERWENT SPINAL FUSION USING INDUCTIGRAFT AS A BONE GRAFT SUBSTITUTE, FOR TREATMENT OF SPONDYLOSIS, A DEGENERATIVE OSTEOARTHRITIS OF THE JOINTS BETWEEN THE CENTER OF THE SPINAL VERTEBRAE AND/OR NEURAL FORAMINA. EIGHT MONTHS POSTOPERATIVE, THE PEDICAL SCREW INSERTED DURING THIS PROCEDURE BROKE CAUSING COMPRESSION ON THE SURROUNDING NERVES AND TISSUE, LEADING TO AN INCREASE IN PAIN, NEUROGENIC INTERMITTENT CLAUDICATION (CLAUDICATION SPINALIS) PERIODIC EPISODES OF PAIN/WEAKNESS IN THE LEGS, AND LUMBAR SCIATICA (LUMBOSCIATICA) OR PAIN WHICH ORIGINATES IN THE LUMBAR SPINE AND RADIATES DOWN THE LEG. THE PATIENT REQUIRED REVISION SURGERY WHICH WAS COMPLETED ON (B)(6) 2013. ALTHOUGH INDUCTIGRAFT IS NOT WEIGHT BEARING, AND NEW BONE FORMATION NEEDS AT LEAST 12 MONTHS, THERE SHOULD BE A GOOD AMOUNT OF NEW BONE FORMATION. A CONTRIBUTION OF INDUCTIGRAFT TO THE MECHANICAL COMPLICATION OF FRACTURE OF A PEDICLE SCREW 8 MONTHS POST INSERTION CANNOT BE RULED OUT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER (B)(4) COMPLETED INVESTIGATION. NO SAMPLE WAS AVAILABLE THEREFORE SAMPLE EVALUATION WAS NOT PERFORMED. BATCH RECORD REVIEW WAS PERFORMED AND ALL RELEASE/TESTING SPECIFICATIONS WERE MET. PER (B)(4), THERE WERE FIVE DEVIATIONS REPORTED DURING THE MANUFACTURE AND PACKING OF THIS BATCH HOWEVER NONE OF THE DEVIATIONS WERE DEEMED TO AFFECT OR RESULT IN THE EVENT REPORTED. NO TREND WAS IDENTIFIED. PER (B)(4), BASED ON THE INFORMATION PROVIDED, NO FURTHER INVESTIGATION IS NECESSARY. (B)(4). THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    PLEASE KNOW THAT INDUCTI-GRAFT IS NOT REGISTERED IN THE US. IT IS HAS SIMILAR COMPOSITION TO ACTIFUSE BONE GRAFT SUBSTITUTE (B)(4). PROTOCOL #: (B)(4). SITE REPORTED AE-TERM: BREAKAGE OF SPONDYLODESIS SITE REPORTED ADVERSE EVENT: LOOSENING OF PEDICLE SCREW AND BREAKAGE OF SPONDYLODESIS ADMISSION DATE: (B)(6) 2013. DATE OF OPERATION: (B)(6) 2012. ONSET OF FIRST SIGNS/SYMPTOMS OF AE: (B)(6) 2013; 1100. TIME ELAPSED BETWEEN OPERATION AND ONSET OF FIRST SIGNS/SYMPTOMS OF AE: 8 MONTHS. CORRECTIVE SURGERY TO TREAT AE: REVISION SURGERY ON (B)(6) 2013, WITH EXCHANGE OF THE SPONDYLODESIS MATERIAL. IMPLANTATION OF CAGES L3/4, L4/5 AND L5/S1. SUBJECTS RELEVANT MEDICAL HISTORY: HYPERTENSION, CORONARY DISEASES, AND HYPOTHYREOSIS SITE REPORTED SERIOUSNESS CRITERIA: INVOLVED OR PROLONGED HOSPITALIZATION SITE REPORTED SEVERITY: MODERATE SITE REPORTED OUTCOME: RESOLVED ON (B)(6) 2013. EVENT DESCRIPTION: PAIN EXACERBATION, LUMBOSCIATICA, CLAUDICATION SPINALIS THE REPORTING FACILITY DEEMED THIS CASE LIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212209 INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD ELN83F1117FP

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other