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 Problems Neuropathy (1983); Pain (1994); Swelling (2091); Blurred Vision (2137); Weakness (2145); Burning Sensation (2146); Tingling (2171); Ulcer (2274); Numbness (2415); Ambulation Difficulties (2544)

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 on (b)(6) 2004, the patient underwent a spinal fusion surgery (anterior lumbar interbody fusion and posterior lumbar fusion surgery) on the lumbar region of his spine from vertebrae l4 to s1.Reportedly, during the surgery, select parts of rhbmp-2/acs (i.E.Only the rhbmp-2 and collagen sponge) were used in the patient from a posterior approach.It was also reported that the rhbmp-2 collagen sponge was placed outside a cage (i.E., facets and posterolateral elements).As reported, the patient's post-operative period had been marked by a period of chronic and severe lower back pain, numbness and burning; pain and radiculopathy into his lower extremities; difficulty standing and sitting; inability to walk too far; and occasional use of a back brace.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2000 the patient presented with the complaint of painful degenerative disc disease, l4-5 and l5-s1.The patient underwent the following procedures: intradiscal electrothermal annuloplasty, l5-s1, bilateral approach, right sided needle placement.Intradiscal electrothermal treatment, l4-5, bilateral approach.Intravenous conscious sedation with versed, fentanyl and inaspine with monitoring.Fluoroscopic guided needle placement in surgical procedure, l4-5 and l5-s1.Intradiscal injection of antibiotics and local anesthesic.On (b)(6) 2004 the patient underwent mri of the lumbar spine without contrast due to low back pain and bilateral leg pain.Impression : small left paracentral disc herniation l5-s1 contacts the left s1 nerve root.Small posterior central disc herniation l4-5 with mild narrowing of the spinal canal.No definite nerve root impingement.Degenerative disc changes at l1-2, l4-5, and l5-s1 with disc dehydration, loss of disc height, and annular bulges.Mild degenerative facet changes bilaterally at l4-5.On (b)(6) 2004 the patient presented with the preoperative diagnosis; left zygomatic arch fracture (depressed).Nonrestorable tooth #31.Procedure performed: open reduction of the left zygomatic arch fracture using the gillies approach.Extraction of tooth #31.On (b)(6) 2004 the patient presented with the following preoperative diagnoses and complained of back pain: degenerative disc disease, l4-5.Degenerative disc disease, l5-s1.The following operative procedures were performed on the patient: anterior interbody fusion, l4-5.Anterior interbody fusion, l5-s1.Insertion of intervertebral implant, l4-5, with bone morphogenic protein (bmp), medium dose.Intervertebral interbody implant , l5-s1, with the remainder of the medium dose of bmp.Only 1 dose of bmp was used.Posterior fusion, l4 to the sacrum, using local bone, bone graft, and the leftover bmp.Pedicle screw fixation with screws placed in the pedicle of l4, the pedicle of l5, and the pedicle of the sacrum on the left; and the pedicle of l4 and the pedicle of the sacrum on the right, using tsr-30.Per op notes: the working channel was then impacted into the disc space and the distractor removed.The surgeon then shaved 2 mm off each end plate, getting down to a nice, smooth, bleeding, cortical, cancellous bone using the local bone shavings, combining that with the bmp and a small amount of bone graft to place into the implant.A 16-mm implant was used, impacted into the disc space, and countersunk appropriately.Position of this device was excellent.Because they had some small amount of remaining bmp and bone graft and the surgeon could get some local bone from the lamina of l4 and l5, this is what he used for our bone graft posteriorly.The surgeon then decorticated the facets and the dorsal elements of l4 and l5 and used local bone and bmp and bone graft and the putty, whatever was left from the anterior part, as our graft dorsally only.The patient also underwent retroperitoneal exposure of the anterior lumbar spine for interbody fusion of the l4-l5 and l5-s1 interspaces and assistance at placement of interbody fusion prosthesis due to degenerative disk disease, l4-l5 and l5-s1.The patient underwent x-ray of the lumbar spine.Impression: pedicular screws are identified from l4 to s1 in good position.Stable interbody bony fusion at l4-l5 and l5-s1.On (b)(6) 2004 the patient underwent the x-ray of the chest.Impression: normal portable chest.On (b)(6) 2004 the patient presented for a follow up visit.Impression: status post anterior posterior fusion from l4 to s1.Chronic narcotic use as well as methadone use.On (b)(6) 2004 the patient presented for a follow up visit.The patient underwent x-ray of the lumbar spine.Impression: there are disc cages, rods and pedicle screws fixing l4 through s1.Alignment is within normal limits and there are no acute abnormalities.On (b)(6) 2004 the patient underwent ct of the lumbar spine due to lumbar fusion and back pain.Impression: satisfactory ct appearance of interbody and posterior fusions with instrumentation including l4 to s1.Postoperative changes are new in comparison with prior study.Central canal at l4-5 and l5-s1 are well decompressed.Findings are compatible with maturing right dorsolateral fusion bone from l4 to s1.On (b)(6) 2004 the patient presented with chief complaint of pain in the left leg.On (b)(6) 2004 the patient presented with chief complaint of left leg pain.Impression: ongoing left lower extremity pain in a patient who underwent a two-level anterior/posterior fusion on (b)(6) 2004.On (b)(6) 2005 the patient underwent ct scan of the lumbosacral spine due to low back and left leg pain with tingling and weakness.On (b)(6) 2005 the patient underwent ct scan of the abdomen and pelvis.Impression: a 1.5 cm indeterminate nodular density in the left lower lobe.Postoperative changes in the lower lumbar spine.No acute traumatic changes.The patient also underwent ct of the lumbar spine.Impression: fusion from l4 to s1.No acute abnormalities are identified.The patient also underwent the x-ray of the lateral chest.Impression: nondisplaced fracture of the left eighth rib laterally.If clinically indicated, dedicated rib series may provide more information.Conclusion: solid-appearing interbody fusions at both l5-s1 and l4-5 with evidence of dorsolateral spinal fusion on the right at each level and with no residual central or lateral canal stenosis.No abnormalities are visualized within the supra-adjacent l3-4 level nor within the upper sacrum.Moderate to advanced disc degeneration at l1-2 with moderate circumferential bulging of the disc annulus and no significant central or lateral canal stenosis.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2010: patient underwent x-ray of lumbar spine due to low back pain.Impression: no evidence of acute pathology status post fusion, l4 through s1.Patient underwent x-ray of pelvis due to low back pain.Impression: no evidence of acute pathology.

Event Description

It was reported that on, (b)(6) 2004 the patient presented for a post-op wound check.On (b)(6) 2005 the patient underwent ct scan of the lumbosacral spine due to low back and left leg pain with tingling and weakness.Conclusion: solid appearing interbody fusion at both l5-s1 and l4-5 with evidence of dorsolateral spinal fusion on the right at each level with no residual central or lateral canal stenosis.No abnormalities are visualized within the supra-adjacent l3-4 level nor within the upper sanctum.Moderate to advanced disc degeneration at l1-2 with moderate circumferential bulging of the disc annulus and no significant central or lateral canal stenosis.

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2003, patient presented for office visit to establish primary care.On (b)(6) 2008, patient presented for office visit with rectal pain.Patient also reported chronic back pain since back surgery two years ago.On (b)(6) 2008, patient presented for office visit with complaint of right eye pain and decreased vision.Patient underwent ct of orbits without contrast.Impression: no evidence of foreign body in the right eye; nodular thickening at the lateral aspect of the eye globe, of uncertain clinical significance.Recommended clinical correlation; multiple dental caries, with periapical abscesses demonstrated about the incisors; old left lamina papyracea and zygomatic arch fractures.On (b)(6) 2008, (b)(6) 2009, patient presented for follow-up on right eye ulcer.On (b)(6) 2014, patient presented with finger laceration.On (b)(6) 2014: patient presented for wound check post laceration sustained from metal grinder.On (b)(6) 2014: patient presented with complaints of blurry vision, double vision, photosensitivity, headache and dizziness.On (b)(6) 2014, patient presented in emergency department with complaint of painful, swollen and throbbing index finger after cutting it on metal grinder.Patient underwent x-ray of finger.Impression: punctuate debris in the dorsal soft tissue adjacent to the proximal second phalanx may represent foreign body; marginal erosion involving the middle phalanx, radial aspect, at the dip joint.It is uncertain if this is related to trauma.Gout can have a similar appearance.

• 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: 5403423
• MDR Text Key: 37302538
• Report Number: 1030489-2016-00356
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2017

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 Catalogue Number: 7510400
• Device Lot Number: M112003ABD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/18/2016; 07/08/2016; 08/22/2016; 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 65