BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4171448 · Received October 14, 2014

    Report

    Report Number
    1030489-2014-04028
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2004: THE PATIENT UNDERWENT FUSION SURGERY USING RHBMP-2/ACS. PER-OP NOTES CARTILAGINOUS ENDPLATE ABOVE AND BELOW WAS SCRAPED AWAY BACK TO GOOD BLEEDING SUBCHORDRAL ENDPLATE BONE. PREVIOUSLY HARVESTED AUTOGRAFT BONE LOCALLY OBTAINED WAS MIXED WITH BONE MORPHOGENIC PROTEIN ABSORBED TO THE COLLAGEN MATRIX SPONGE. THIS MIXTURE WAS PACKED INTO THE INTERSPACE AT L4-L5 AND L5-S1 AGAINST THE ANTERIOR LONGITUDINAL LIGAMENT. ANTERIOR INSTRUMENTATION WAS PERFORMED AT L4-L5 AND L5-S1 WAS NOW PERFORMED BY FASHIONING A POLYMER CAGE WITH APPROPRIATE DIAMETER. IT WAS PACKED WITH THE BONE MORPHOGENIC PROTEIN SPONGE AND IMPACTED INTO THE INTERSPACE AT L4-5 AND L5-S1 AN ANATOMIC CENTER-CENTER POSITION AND EXCELLENT PRESS - FIT AND EXCELLENT RESTORATION OF LORDOSIS WAS ACHIEVED. ADDITIONAL LOCAL AUTOGRAFT BONE WAS PACKED AROUND THE CAGE. C-ARM FLUOROSCOPY WAS USED TO CONFIRM POSITION AND ALIGNMENT OF THE GUIDE PINS. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012: THE PATIENT UNDERWENT A CT OF THE LUMBAR SPINE WITHOUT CONTRAST. THE PATIENT HAS HAD RECENT INCREASES IN UPPER EXTREMITY PARESTHESIAS. FINDINGS: INTERPEDICULAR SCREWS AND POSTERIOR FIXATION RODS FROM L2-L5. THERE HAS BEEN PREVIOUS DISCECTOMY AT L4-5 AND L5-S1. ON (B)(6) 2012: THE PATIENT PRESENTED WITH BACK PAIN AND A HISTORY OF EXTENSIVE CERVICAL AND THORACOLUMBAR FUSION. THE PATIENT UNDERWENT A FLUOROSCOPIC-GUIDED LUMBAR PUNCTURE. PER THE PROCEDURE NOTES, SEVERAL ATTEMPTS TO ACCESS THE THECAL SAC WITH 22 GAUGE SPINAL NEEDLE WAS UNSUCCESSFUL AS THERE WAS EXTENSIVE OSSIFICATION DORSAL TO THE SPINOUS PROCESSES RESULTING IN FUSION OF THE LUMBAR SPINE. THIS OSSIFICATION PREVENTED ACCESS TO THE THECAL SAC. PROCEDURE WAS ABORTED. THE PATIENT WAS SENT TO UNDERGO A CT SCAN. THE SCAN DEMONSTRATED DIFFUSE OSSIFICATION DORSAL TO THE SPINOUS PROCESSES WITHOUT AXIS AND THE FORAMINA ARE MORE DORSALLY OBSTRUCTED BY THE OSSIFICATION. IMPRESSION: EXTENSIVE OSSIFICATION OF THE POSTERIOR INTERLAMINAR SPACES; UNSUCCESSFUL FLUOROSCOPICALLY GUIDED LUMBAR PUNCTURE SINCE THERE WAS NO PATENT INTERLAMINAR SPACE. IT WAS REPORTED THAT THE PATIENT DEVELOPED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650546 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other