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

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

Patient Problems Pain (1994); Stenosis (2263); Injury (2348); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

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) 2007 the patient underwent a lumbar fusion spinal surgery in which rhbmp-2/acs was used.Patient alleges unspecified injury due to the use of rhbmp-2.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2007: the patient underwent ct of the lumbar spine without contrast.Impression: status post posterior decompression and fusion of the l3-l4 and l4-l5 intervertebral discs.Metallic hardware spans the l2 through l5 vertebral levels.Partial incorporation of the intervertebral disc grafts into the adjacent vertebral end plates.On (b)(6) 2008 the patient underwent removal of symptomatic hardware, lumbar spine, status post lumbar fusion.Indications: a (b)(6) female with status post lumbar surgery for persistent back pain, requested hardware to be removed.On (b)(6) 2009: the patient underwent mri of lumbar spine with <(>&<)> without contrast due to low back pain.Impressions: status post laminectomies at l3-l4 and l4-l5 with interbody fusions.Interval l5-s1 laminectomy.Interval removal of posterior fusion hardware.There is normal vertebral body alignment at l3-s1.Progression of disc protrusion at l1-l2 with mild spinal canal compromise.Stable slight posterior displacement of l2 on l3.Mild to moderate bilateral neural foraminal encroachment at l5-s1, stable.Some minimal left neural foraminal encroachment at l3-l4, which is felt to be stable.On (b)(6) 2010: patient presented with complaints of low and upper back pain.Patient has l2-l5 fusion in 2003 and removal of hardware in 2008.Pain radiates down the legs and is constantly radiating into the back and posterior thighs.On physical examination she has difficulty balancing and standing on her toes and on her heels.Single leg stance is not intact on either side and heel to shin testing is difficult for her.Otherwise she has tenderness over the lumbosacral junction and off to the posterior superior spine on either side.Her x-rays and ct scan was reviewed which shows an obvious vacuum sign anteriorly at l4-5 and l5-s1 with no evidence of significant anterior or posterior fusion.However there is significant degenerative change with bone on bone.Both of these levels seem to be a non union.There is a solid fusion at l2-3 and l3-4.On an unknown date the patient was observed with non union at l4-5 and l5-s1.Due to which the patient underwent a revision surgery on (b)(6) 2010.

Event Description

It was reported that on: (b)(6) 2008: the patient underwent following procedures : removal of symptomatic hardware, lumbar spine, status post lumbar fusion.On (b)(6) 2009: the patient underwent right sided l5-s1 facet injection.Impression: technically successfully right-sided l5-s1 facet injection.On (b)(6) 2009: the patient underwent bilateral sacroiliac joint injections.Impressions: technically successful bilateral si joint inj ections.On (b)(6) 2010: the patient underwent mri of lumbar spine without contrast due to back pain and previous surgery.Impression: foraminal stenosis.On (b)(6) 2010: the patient underwent ct lumbar spine due to back pain.Impression: extensive postoperative change.

Event Description

It was reported that on (b)(6) 2009: the patient underwent right sided l5-s1 facet injection.Impression:technically successfully right-sided l5-s1 facet injection.On (b)(6) 2009: the patient underwent bilateral sacroiliac joint injections.Impressions:technically successful bilateral si joint injections.On (b)(6) 2010: the patient underwent ct lumbar spine due to back pain.Impression:extensive postoperative change.

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.

• 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: 6521305
• MDR Text Key: 73664702
• Report Number: 1030489-2017-00998
• 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: 07/14/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided; 07/07/2017; 07/14/2017; 07/14/2017; 07/14/2017
• Supplement Dates FDA Received: 05/24/2017; 08/04/2017; 08/11/2017; 10/02/2017; 10/03/2017
• 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