BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2925329 · Received January 22, 2013

    Report

    Report Number
    1030489-2013-00198
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    May 17, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RADIOGRAPHIC IMAGING STUDIES FOUND AS FOLLOWS: ON (B)(6) 2009 LUMBAR CT POST DISCOGRAM CT PERFORMED WHICH SHOWS SOME SPREADING OF NUCLEAR CONTRAST AT L4 AND L5 SUGGESTIVE OF DEGENERATIVE DISC DISEASE. L3/4 LEVEL APPEARS MORE NORMAL IN APPEARANCE. NO EPIDURAL CONTRAST IS NOTED. ON (B)(6) 2009 AP AND LATERAL LUMBAR XRAYS SHOW UNILATERAL L5/S1 PEDICLE SCREWS WITH TITANIUM TLIF CAGE. ON (B)(6) 2009 AP AND LATERAL LUMBAR FILMS SHOW SAME CONSTRUCT AS ABOVE. NO PATHOLOGY IDENTIFIED AT ANY OTHER LEVELS. ON (B)(6) 2009 ABDOMINAL CT SHOWS NO OTHER SPINAL PATHOLOGY. LARGE SPUR IS NOTED LEFT L5/S1 AT THE JUNCTION OF THE ALA AND DISC SPACE, VENTRAL TO THE L5 ROOT. ON (B)(6) 2010 LUMBAR CT AGAIN SHOWS L5/S1 TLIF WITH UNILATERAL SCREWS ON THE LEFT. SCREWS ARE IN GOOD POSITION. BONE GRAFT IS PRESENT WITHIN THE DISC SPACE. MILD STENOSIS IS NOTED AT L4/5. THERE IS SOME CALCIFICATION WITHIN THE CANAL AT L5 HOWEVER ALL OF IT IS VENTRAL TO THE POSTERIOR S1 BORDER, SUGGESTING CALCIFICATION WITHIN THE ANNULUS OF L5 RATHER THAN WITHIN THE CANAL. LARGE SPUR IS PRESENT AT THE ANTERIOR JUNCTION OF THE LEFT SACRAL ALA AND S1 BODY, JUST VENTRAL TO THE L5 ROOT AT THE LEVEL OF THE DISC.

    Additional Manufacturer Narrative · 1

    (B)(6). (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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CT SCAN OF THE LUMBAR SPINE INDICATED "AT L4-5 ... A GENERALIZED DISC BULGE AND ... SMALL FOCAL DISC PROTRUSIONS POSTERIORLY CENTRALLY AND POSTEROLATERALLY ON THE RIGHT. AT L5-S1 ... GENERALIZED DISC BULGE BOTH POSTERIORLY AND LATERALLY ON THE LEFT. THERE IS CONSIDERABLE POSTERIOR VERTEBRAL SPURRING AND THERE IS FOCAL LEFT LATERAL VERTEBRAL SPURRING." THE PATIENT UNDERWENT MINIMALLY INVASIVE TLIF L5-S1 ON THE LEFT TO TREAT LUMBAR DISC DEGENERATION L5-S1, DISC HERNIATIONS AT L4-5 AND L5-S1 AND MILD SCOLIOSIS. AN INTERBODY DEVICE, PUTTY, PEDICLE SCREWS AND ROD, AND RHBMP-2/ACS WERE USED. THERE WAS AN INCIDENTAL SMALL DURAL LACERATION THAT WAS REPAIRED INTRAOPERATIVELY. PER THE OPERATIVE NOTES, "I TRIED TO INCISE INTO THE ANNULUS BUT THERE WAS A HARD CALCIFICATION OVER THE TOP OF THE ANNULUS ACROSS THIS SIDE AND SO I HAD TO USE OSTEOTOMES TO BREAK INTO THE DISK SPACE AND BREAK THROUGH THIS OUTER SHELL OF CALCIUM COVERING THE ANNULUS, AND DID FIND SOME VERY ABNORMAL DISK MATERIAL JUST BELOW THAT SHELL. THERE MAY HAVE BEEN AREAS WHERE SOME OF THAT WAS WORKING ITS WAY OUT A LITTLE BIT. AT ANY RATE, I REMOVED QUITE A BIT OF THIS CALCIFIED MATERIAL ALONG WITH SOME OF THE DISK MATERIAL FROM THIS LEFT SIDE AND OVER AS FAR AS I COULD GET CENTRALLY. STILL SOME MATERIAL REMAINED OVER THERE." AT 442 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK STIFFNESS. A CT SCAN OF THE LUMBAR SPINE INDICATED "THERE IS A MILD POSTERIOR OSTEOPHYTE FORMATION AT THE L5-S1 LEVEL ENCROACHING ON THE SPINAL CANAL MEDIATING PREDOMINANTLY RIGHT-SIDED NEURAL FORAMINAL ENCROACHMENT. ... INTACT POSTERIOR FUSION ON THE LEFT SIDE AT THE L5-S1 LEVEL. DEVELOPING OSTEOPHYTE FORMATION AT THE L5-S1 LEVEL AS DESCRIBED. MILD RETROLISTHESIS OF L3 ON L4. NO ACUTE ABNORMALITY IDENTIFIED." REPORTEDLY THE PATIENT HAS DEVELOPED "SIGNIFICANT PAIN AND [IS] CONSTANTLY WORRIED ABOUT WHETHER THINGS WILL GET WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: LUMBAR DISK DEGENERATION WITH POSITIVE DISKOGRAPHY AT L5-S1; DISK HERNIATIONS AT L4-5 AND L5-S1; MILD SCOLIOSIS. PATIENT UNDERWENT FOLLOWING PROCEDURES: MINIMALLY INVASIVE TRANSFORAMINAL DECOMPRESSION AND MICRODISKECTOMY AT L5-S1 ON THE LEFT; MICROSURGICAL REPAIR OF SMALL DURAL LACERATION ON THE LEFT; INTERBODY FUSION OF L5-S1 (BMP-II BONE GROWTH MATERIAL); PLACEMENT OF INTERBODY DEVICE L5-S1 (SPINAL USA 11 X 25 MM TITANIUM); POSTEROLATERAL FUSION L5-S1 LEFT (ACTIFUSE PUTTY); NON-SEGMENTAL FIXATION OF L5-S1 LEFT (ZIMMER TITLE PEDICLE SCREWS AND ROD).NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30520 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