BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTIGRAFT

    MDR report key: 3159482 · Received June 10, 2013

    Report

    Report Number
    2032282-2013-00057
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 6, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: PATIENT UNDERWENT SPINAL LUMBAR FUSION USING INDUCTIGRAFT AS A BONE GRAFT SUBSTITUTE, FOR TREATMENT OF DEGENERATIVE SPINE DISEASE (SPONDYLODESIS). TWELVE MONTHS POSTOPERATIVE, THE PEDICLE SCREW INSERTED DURING THIS PROCEDURE WERE FOUND LOOSE AND SPINAL INSTABILITY HAS BEEN DIAGNOSED, LEADING TO A PERSISTING POSTOPERATIVE PAIN. THE PATIENT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2013. ALTHOUGH INDUCTIGRAFT IS NOT WEIGHT BEARING, AND NEW BONE FORMATION NEEDS AT LEAST 12 MONTHS, AFTER THIS PERIOD THERE SHOULD BE A GOOD AMOUNT OF NEW BONE FORMATION AND FUSION OF THE SITE. A CONTRIBUTION OF INDUCTIGRAFT TO THE MECHANICAL COMPLICATION OF PEDICLE SCREW LOOSENING 12 MONTHS POST INSERTION CANNOT BE RULED OUT. PLEASE KNOW THAT INDUCTIGRAFT IS NOT REGISTERED IN THE US. IT HAS SIMILAR COMPOSITION TO ACTIFUSE BONE GRAFT SUBSTITUTE (K081979). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE. BATCH RECORD REVIEW WAS PERFORMED AND INDICATED THAT ALL RELEASE/TESTING SPECIFICATIONS WERE MET FOR THIS LOT AND NO DEVIATIONS WERE IDENTIFIED THAT COULD OF AFFECTED OR RESULTED IN THE EVENT REPORTED. THE MANUFACTURING FACILITY DETERMINED THAT NO FURTHER INVESTIGATION IS POSSIBLE AS NO SAMPLE WAS PROVIDED AND THE BATCH REVIEW WAS SATISFACTORY FOR THIS LOT. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS RE-OPENED AS ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED FROM A CLINICAL STUDY THAT THE PATIENTS' SYMPTOMS RESOLVED ON (B)(6) 2013 AFTER A REVISION SPONDYLODESIS IN WHICH INDUCTIGRAFT WAS USED. THE ADDITIONAL INFORMATION HAS NOT CHANGED THE MEDICAL ASSESSMENT. THIS CASE REMAINS RELATED TO THE PRODUCT. AS THIS IS A CLINICAL TRIAL, THE CSTL WILL BE NOTIFIED OF THE CLOSURE. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE FOLLOWING IS A REPORT OF AN ADVERSE EVENT RECEIVED FROM (B)(6) ON (B)(6) 2013. (B)(4), (B)(6); GENDER: MALE. ADMISSION DATE: (B)(6) 2013. DATE OF OPERATION: (B)(6)2013. SITE REPORTED ADVERSE EVENT: PEDICLE SCREW LOOSENING. ONSET OF FIRST SIGNS/SYMPTOMS OF AE: (B)(6) 2013 AT 0930. SITE REPORTED SERIOUSNESS CRITERIA: INVOLVED OR PROLONGED HOSPITALIZATION. SITE REPORTED SEVERITY: SEVERE. SITE REPORTED OUTCOME: UNRESOLVED/ONGOING. DIAGNOSED PEDICLE SCREW LOOSENING IN 12 MONTH'S CT - LWS. PERSISTING PAIN AFTER SPONDYLODESIS IN THE LOWER BACK. REVISION SURGERY PLANNED FOR (B)(6) 2013. L4 REVISION SPONDYLODESIS. THE FACILITY DEEMED THIS CASE LIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 22-SEP-2014: ACTION TAKEN: REVISION SPONDYLODESIS. OUTCOME: RESOLVED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260950 INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD ELN83F0517MP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other