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

Catalog Number 7510200

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

Patient Problems Abdominal Pain (1685); Arthritis (1723); Pain (1994); Tingling (2171); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4) - (persisting back pain, disc herniation).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.

Event Description

It was reported that on (b)(6) 2009, patient underwent the following surgeries: removal of anterior peek device with partial osteotomy of l4 and l5 vertebral bodies in order to allow for appropriate device removal (peek interbody device).Anterior spinal fusion, l4-5 (interbody fusion).Insertion of machined threaded cortical allograft bone dowel l4-5.Aspiration of bone marrow aspirate from l4 vertebral body.Local bone grafting.Anterior lumbar plating l4-l5 with plate using the following implants: an 18 mm machined threaded cortical allograft bone dowel x1.Small rhbmp-2 kit.Allograft 10 ml graft extender putty.Plate with 26 mm screws x 4 to treat the following pre-op diagnosis: persistent pseudoarthrosis l4-5 status post l4-5 decompression fusion with tlif.Morbid obesity made the exposure, the removal of an anterior device and the anterior fusion with plating at least 50% more challenging than usual.Per operative notes: ¿¿ this was in turn then mixed with 2 rhbmp-2 sponges and placed both within the disk space and within the machined threaded cortical allograft bone dowel¿ the patient was transferred to the recovery room bed in satisfactory condition.On (b)(6) 2009, patient presented for an office visit due to pseudoarthrosis, abdominal pain.Imaging: two view lumbar x-rays were obtained and reviewed.X-rays reveal large interbody cage at l4-5 with anterior plate.On (b)(6) 2009, patient presented for an office visit due to three months status post revision fusion at l4-5, abdominal pain that was now resolving.Imaging and other tests: two view lumbar x-rays were obtained and reviewed.X-rays reveal excellent placement of an interbody graft at l4-5 with the appearance of a fusion mass.Posterior hardware was intact.On (b)(6) 2009, patient presented to show his six week¿s status post anterior interbody fusion with excellent clinical improvement in symptoms.On (b)(6) 2009, patient presented for an office visit due to six-month¿s post lumbar decompression and revision fusion l4-5.On (b)(6) 2010, patient underwent two-views lumbar x-rays were obtained and reviewed.X-rays revealed the appearance of a solid interbody fusion, l4-5.Hardware was intact and stable.On (b)(6) 2012, patient presented with status post lumbar fusion, l4-5.Patient had occasional achiness in his low back.On (b)(6) 2012, patient presented for an office visit due to back pain due to a motor vehicle accident.Imaging and other tests: four view lumbar x-rays were obtained and reviewed.X-rays reveal the appearance of a solid interbody and dorsal fusion at l4-5.Relative disc height collapse at l5-s1.Normal sagittal and coronal alignment.No fracture.No instability.No hardware malfunction.On (b)(6) 2012, patient underwent mri of lumbar without contrast.Conclusion: small asymmetric left posterolateral l2-3 disc protrusion superimposed upon short pedicles and developmentally small canal.Developmentally small central spinal canal at l3-4 with normal disc and annular margin and mild right facet hypertrophy.L5-s1 left facet hypertrophy without stenosis or neural impingement.The fusion appears solid by mr criteria anteriorly and posteriorly at l4-5 without complications.On (b)(6) 2012, patient presented for an office visit due to acute low back pain and pain down his right lower extremity and numbness and tingling.Patient underwent a mri scan of his lumbar spine.Mri scan reveals no significant disc pathology at l5-1 or l3-4.He does have an annular bulge at l2-3, but this was more so on the left.It does extend into the left neural foramen.No obvious fractures.No other significant findings.On (b)(6) 2013, patient presented for an office visit due to continued low back pain as well as intermittent right thigh pain status post motor vehicle accident.He also continued to get headache since his accident.Patient had four-view cervical radiographs after our visit.Impression: some mild degenerative osteophyte at the top of the inferior aspect of the c5 vertebral body that almost articulates with the c6 superior vertebral body.There was also a small anterior osteophyte at the anterior aspect of the c4 vertebral body and appears to be some calcification in both the anterior discs at c4-5 and c5-6.There was no evidence of any subluxation upon flexion and extension.There was no evidence of any fractures.There was some mild arthritic changes noted in the joints mainly at the c5-6 and c6-7.On (b)(6) 2013, patient presented due pain management follow up and procedure report.Patient had low back pain with aggravation of facet arthropathy at l3-4 and l5-s1, status post mva-related straining injury with a background of prior lumbar fusion at l4-5.Patient underwent the following procedures: intraarticular zygapophyseal joint injections at l3-4 and l5-s1 bilaterally with confirmatory arthrograms under fluoroscopy followed by intraarticular injection with a combination of a diagnostic concentration of lidocaine combine with potentially therapeutic depo-medrol in each of the four joints.On (b)(6)2013, patient underwent bilateral l3-4 and l5-s1 facet joint injections.On (b)(6) 2013, patient presented for an office visit due to his back pain.

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) 2012: patient underwent mri of lumbar spine without contrast.Conclusion: small asymmetric left posterolateral l2-3 disc protrusion superimposed upon short pedicles and developmentally small canal; developmentally small central spinal canal at l3-4 with normal disc and annular margin and mild right facet hypertrophy; l5-s1 left facet hypertrophy without stenosis or neural impingement; the fusion appears solid by mr criteria anteriorly and posteriorly at l4-5 without complications.

Event Description

It was reported that on (b)(6) 2009: the patient underwent x-ray due to l4-5 anterior fusion.Impression: probable prior l4-5 posterior spinal fusion with new l4-5 anterior spinal fusion.On (b)(6) 2009: the patient was discharged.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5688037
• MDR Text Key: 46162660
• Report Number: 1030489-2016-01593
• 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
• Report Date: 07/08/2016

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: 03/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110802AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/08/2016
• Supplement Dates FDA Received: 07/12/2016; 07/25/2016; 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2009
• 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