MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that (b)(6) 2008 patient underwent mri of neck cervical strain.(b)(6) 2008 patient presented with back pain for bilateral l4-5 facet injections.Findings: limited views of the lumbar spine show minimal degenerative change.Bilateral l4-5 facet injections performed without complication.Impression: bilateral l4-5 facet injections.(b)(6) 2008 patient presented due to low back pain, lumbar disc degeneration for lumbar discogram, 4 level.Findings: the patient's baseline pain is in her central low back.The pain radiates to her right flank and left hip.The pain extends to the back of both thighs down to the knee level.The patient's pain today is very severe.The patient has been off of her pain medications for 24 hours.Her baseline pain today she states is at a 9 out of 10 level of severity.The patient is crying and tearful during positioning on the table.L2-3: the patient experienced pressure only on l2-3 injection.The pressure was felt in the right hip.The patient experienced no significant pain initially on u-3 injection.Later, the patient did complain of pain, but this was fairly poorly defined in the mid back and was not concordant with pre-procedure symptoms.The disc accepted 1.5 cc.Of contrast.Disc consistency is firm.The images reveal normal appearing nucleus pulposus cavity with a normal intranuclear cleft.No significant contrast extravasation is seen.L3-4: the patient experienced severe low back pa-n and left hip pain, 10 out of 10 in severity, but different from and discordant with her preprocedure symptoms.The patient states that she has never felt pain similar to this before.The patient did not experience any pain concordant with her pre-procedure symptoms on l3-4 injection.The disc accepted 2 cc.Of contrast and disc consistency was moderate, the images reveal left far lateral full thickness annular tear with contrast extravasation into the paradiscal soft tissues.There is a mild degree of internal annular fissuring to the right, but there is partial preservation of the intranuclear cleft.L4-5: this is a classically positive level.The patient experienced severe low back pain centrally, identical with the majority of the pre-procedure symptoms.The disc accepted 4 cc.Of contrast.Disc consistency was soft.Images reveal advanced degeneration of the disc with multiple circumferential full thickness annular tears and expansion of the nucleus pulposus cavity.There is contrast extravasation into the ventral epidural space centrally through a central annular tear.L5: this is an equivocal positive level.The patient experienced low back pain moderate to severe in degree, although the patient had difficulty describing the pain or telling me whether it was the same as her usual symptomatic pain or not.The patient at this point was fairly tearful and had a hard time expressing herself following the pain experienced at the l4 injection.She did state that she thought that this was part of her normal pain near the end of the l5-s1 injection.The disc accepted 3.5 cc.Of contrast and disc consistency was moderate.The images reveal a central and left far lateral full thickness annular tear with contrast extravasation into the paradlscal soft tissues.Impression: 1.L2-3 was a negative level.The patient experienced pressure only on the initial l2-3 disc injection and the disc de monstrated normal morphology.2.L3-4 was a negative level relative to pre procedure symptoms, although the patient did experience severe degree of low back and left hip pain different than pre-procedure symptoms on l3-4 injection.The images did show left far lateral full thickness annular tear.3.L4-5 was a classically positive level.The patient experienced 'severe low back pain identical with majority of the pre-procedure symptoms at l4-5 injection.The images show multiple full thickness annular tears and extensive contrast extravasation into the paradiscal soft tissue circumferentially.L5-s1 was equivocal to mildly positive level.The patient had difficulty expressing whether her pain on l5-s1 injection was a portion of pre-procedure symptoms or not, but later stated that she thought it did comprise a portion of her pre-procedure symptoms.The images do show central posterior and right sided far lateral full thickness annular tears and he pain was fairly significant.(b)(6) 2008 patient presented with l4-l5 degenerative spondylolisthesis with lumbar spinal stenosis, lumbar spondylosis, and lumbar radiculopathy using l4-l5 transforaminal lumbar interbody fusion with machined allograft interbody space and posterior percutaneous pedicle screw instrumentation and posterior fusion.Op note: the left l4-l5 facet joint was decorticated and the lamina of the l5-s1 were decorticated.Using operative report biplanar fluoroscopy, left-sided pedicle screws were placed.An annuloctomy was performed and a through discectomy was performed using kerrisons and curets.Once the endplates had been prepared with care to maintain the bony endplates, trial interbody spacers were then placed and removed.A medium rhbmp-2/acs had been prepared.A few globus sustain interbody implants, 15 mm in height x 10 mm in width x 26 mm in length were each filled with a half sponge of rhbmp-2/acs.Two-thirds of the sponge of rhbmp-2/acs was wrapped around master graft matrix.It was placed on the left hand side of the disk space.Grafton matrix was also placed in.The first interbody implant was placed and then tamped to the left-hand side.A third sponge of rhbmp-2/acs wrapped around grafton matrix was placed in the anterior aspect of the disk space and a second interbody implant was placed.These achieved excellent fit.Additional grafton matrix was packed posterior to the interbody implants.Fibrin glue was placed.The epidural space was dried and fibrin glue was used to seal the posterior aspect of the disk space.Floseal was placed on top of the dura.Attention was then turned to the right-sided instrumentation.Once again the same size pedicle screws were placed in the same fashion through a separate incision.All screws were globus pivot system screws.Rods were passed and set screws were placed and compression was applied bilaterally and final torquing was performed.Once this had been completed, local bone from the approach as well as a sponge of rhbmp-2/acs wrapped around local bone was placed in the left l4-l5 facet joint.Residual grafton matrix and local bone was packed on top of this in order to achieve a posterior fusion and a facet fusion.(b)(6) 2008 patient had undergone lumbar discography.This demonstrated severe concordant reproduction of pain at l4-5 and moderate pain at l5-s1 and discordant pain at l3-4.(b)(6) 2008 patient presented with aching in her back with a little radiation to the anterior abdomen.She had little bit of night posterior thigh discomfort.Imaging: ap and lateral views of the lumbar spine demonstrate her hardware and interbody grafting at l4-5 to be in good position.There was no sign of loosening.(b)(6) 2008 patient presented with severe pain down right side of low back and into right leg.(b)(6) 2008 patient called office complaining of some increasing back and right buttock pain.She described her pain in the back radiating to the buttock with some pain radiating to the anterior aspect of the hip.She does have some discomfort into the anterolateral thigh as well.She denied any weakness.Physical exam: reveals some diffuse tenderness over the lumbar spine and diffusely into the buttock.There was no focal tenderness over the greater trochanteric bursa.She demonstrated 5/5 strength throughout the bilateral lower extremities.Imaging: plain films of the lumbar spine reveal the pedicle screw construct to be well positioned and maintained.Interbody device was well maintained and well positioned.There was no sign of graft migration or any signs of loosening or subsidence of the graft.(b)(6) 2008 patient called due to a migraine because of sinus.(b)(6) 2008 patient presented with aching in her lower back with radiation to the right buttock.She does not have any further radicular complaints.(b)(6) 2008 patient called about the pain she had.(b)(6) 2008 patient called to discuss to refill medicines.(b)(6) 2008 patient presented for post op follow-up.Ap and lateral views of the lumbar spine were obtained from patient.(b)(6) 2011 patient underwent ct scan of lumbar spine, radiology report had shown left paracentral disk bulge at l3, l4 that could be compromising the exiting nerve root.Prior disk space fusion at l4, l5.At l5, s1 mild disk bulge.(b)(6) 2011 patient presented with pain for the past four years due to 1.Low back pain.2.Postlaminectomy lumbar region.3.Lumbar spondylosis with facet arthropathy.4.Degenerative disk disease lumbar area with disk bulges.5.Hip pain.6.Sacroiliitis.7.Chronic narcotic use/abuse.(b)(6) 2011, (b)(6) 2011 the patient underwent caudal epidural steroid injection under fluoroscopy due to post laminectomy lumbar, low back pain.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5159299
• MDR Text Key: 28648745
• Report Number: 1030489-2015-02733
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110704AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 57