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

Catalog Number 7510600

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

Patient Problems Abscess (1690); Fatigue (1849); Unspecified Infection (1930); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Stenosis (2263); Injury (2348); Inadequate Pain Relief (2388); 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

Levels: l4-s1 it was reported that on (b)(6) 2006, patient underwent spinal fusion surgery on the lumbar region at l4-s1 where selected parts of r hbmp-2/acs ((i.E only rhbmp-2 and collagen sponge) were used.The rhbmp-2 collagen sponge was placed outside the cage.Post-op, patient complained of worsening pain in the low back with pain and radiculopathy in the lower extremities.Patient continued to experience chronic and severe low back pain and swelling, radiculopathy and weakness in lower extremities.The patient had difficulty in sitting, standing and walking.These serious injuries prevent the patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively, and had otherwise suffered serious and permanent injuries.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2006: patient presented with preop diagnosis as: degenerative disk disease l4-5 and l5-s1 status post posterior fusion at those two levels.For which patient underwent anterior lumbar fusion l4-5 and l5-s1 with total diskectomy and osteophytectomy at l4-5 and l5-s1.The fusion consisted of cortical ring allograft with rhbmp-2 and local bone graft.Per op notes, the l4-5 and l5-s1 were exposed.It was felt that a 16 mm graft would work well.It was filled with rhbmp-2 and inserted.There was a very nice fit.Rhbmp-2 and local bone graft was placed anteriorly.The l4-l5 level was then approached.It was felt that an 18 mm graft would work well.The appropriate graft was selected with rhbmp-2 and inserted.There was a very nice fit anteriorly to that.Posteriorly, a piece of rhbmp-2 was placed within the space between the graft and the annulus and anteriorly, rhbmp-2 and local bone graft was placed as well.On (b)(6) 2006: patient presented with complaint of pain in back and down the legs.On (b)(6) 2006: patient presented with complaint of back pain, patient underwent ct scan and possibility of perirectal abscess was found.On (b)(6) 2006: patient presented with complaint of worsening right leg symptoms including a dysesthetic pain, especially with standing.Diagnosis: two months status post ap fusion l4 to s1 with narcotic dependency issues.On (b)(6) 2006: patient presented with complaint of continued sever back and leg pain into the right groin and anterior thighs.On (b)(6) 2006: patient underwent ct of lumbar spine without contrast due to recurrent back pain, patient status and post lumbar fusion.Impression: status post anterior posterior fusion at the l4, l5 and s1 levels.No hardware complications are seen.The interbody bone graft at s1 may not be fully incorporated yet which is best noted on the sagittal reformats.There is some bony spurring in the right paracentral region at l4-l5 off the interior aspect of l4, but no high-grade central foraminal stenosis is seen.Levels above the fusion appear normal.On (b)(6) 2007: patient presented with complaint of low back pain and is requesting further medication.On (b)(6) 2007: patient presented with complaint of low back pain status post l4-s1 fusion.On (b)(6) 2008: patient presented for pain control and rehabilitation with bilateral leg pain.Mainly right leg pain.Shooting pain and numbness for short amounts of time.On (b)(6) 2008: patient presented for office visit for follow-up and medication refill.On (b)(6) 2009: patient presented with complaint of difficulties with his back.Diagnosis: status post lumbar fusion l4-5 and l5-s1.Possible pain from the hardware versus chronic change related to surgery and chronic pain.On (b)(6) 2009: patient presented with complaint of some degree of pain status post two level fusion l4-5 and l5-s1 in 2006.Patient underwent ct scan which revealed a good fusion at l4-5 and l5-s1.Hardware is retained.On (b)(6) 2009: patient presented with preop diagnosis as: retained hardware, 3 years status post ¿ap¿ fusion l4-5, l5-s1.For which, patient underwent hardware removal and exploration of fusion; 7.5 screws were used throughout.Patient tolerated the procedure well with no complications reported.Post-op diagnosis showed excellent fusion, retained hardware.On (b)(6) 2009: patient presented with complaint of low back pain.On (b)(6) 2010: patient underwent mri of the lumbar spine without and with intravenous contrast.Conclusion: prior interbody fusions l4-l5 and l5-s1 levels with bone grafting.These fusions appear solid.There has been interval removal of the posterior fixation hardware previously present on (b)(6) 2009.Moderate bilateral neural foraminal narrowing at the l3-l4 levels.Mild bilateral neural foraminal narrowing at l4-l5.On (b)(6) 2010: patient underwent x ray of lumbosacral spine due to back pain.Conclusion: no acute changes are seen.No evidence of acute fracture.Postoperative changes seen at the l4 through s1 levels and degenerative changes seen at multiple levels.On (b)(6) 2010: patient presented with complaint of low back pain and leg pain.On (b)(6) 2011, and (b)(6) 2012: patient presented with complaint of low back pain.Diagnosis: lumbar radiculopathy; chronic low back pain.On (b)(6) 2012: patient presented with complaint of sinus pain/pressure, sore throat, body aches, and fatigue.Diagnosis: acute sinusitis, sore throat.On (b)(6) 2012: patient presented for an office visit with complaint of shoulder pain.Diagnosis: shoulder injury.Patient also underwent x-ray of shoulder which was negative for fracture or dislocation.On (b)(6) 2012: patient presented for a follow up visit with complaint of low back pain, right lower limb pain and weakness.On (b)(6) 2012: patient presented for a follow up visit with complaint of low back pain.On (b)(6) 2012: patient presented for an office visit with complaint of chronic low back pain.On (b)(6) 2012: patient presented for an office visit with complaint of right thigh pain and low back pain.Patient x-ray showed an interbody fusion from l4-s1 appeared solid.There are junctional degenerative changes l3-l4.Mri lumbar spine shows junctional stenosis at l3-l4.Impression: l3 for junctional stenosis with right l4 radiculopathy with lateral recess stenosis.On (b)(6) 2012: patient presented for a follow up visit with complaint of severe pain.On (b)(6) 2012: patient presented for an office visit with complaint of leg pain.On (b)(6) 2013: patient presented with complaint of low back pain.Pain radiated to right calf, right foot, left thigh and right thigh.Patient described pain as an ache, numbness, stabbing and pins and needles.Assessment: low back pain; post laminectomy.On (b)(6) 2013: patient presented with complaint of low back pain.Assessment: lumbago; postlaminectomy syndrome of lumbar region.On (b)(6) 2013, (b)(6) 2014,: patient presented with complaint of low back pain and left knee pain.Assessment: lumbago; postlaminectomy syndrome of lumbar region; pain in knee; pain in joint involving lower leg.On (b)(6) 2013: patient underwent mri of left knee status post fall with injury.Conclusion: tearing of the posterior body continuing within the posterior horn medical meniscus.No flap fragment or parameniscal cyst.There is a 1cm loose body within the anterior midline joint.No lateral meniscal tear.The cruciate ligaments are intact.Large knee joint effusion.No evidence for a chondral effect.On (b)(6) 2014: patient presented for an office visit with complaint of persistent severe shoulder pain following a slip and fall on ice a week ago.Assessment: injury on left shoulder; left shoulder pain.On (b)(6) 2014: patient presented for a follow up visit with post shoulder injury.Diagnoses: shoulder injury, left, subsequent encounter; left shoulder pain.On (b)(6) 2014: patient presented with complaint of low back pain and shoulder pain.Assessment: pain in shoulder; postlaminectomy syndrome of lumbar region; pain in knee; pain in joint involving lower leg.On (b)(6) 2015, : patient presented for a follow up visit with complaint of back pain and medication refill.Assessment: lumbago; postlaminectomy syndrome of lumbar region; pain in joint involving lower leg; pain in joint involving shoulder region.

Manufacturer Narrative

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

Event Description

It was reported that on an unknown date,the patient underwent: exposure of l5,s1 vertebral interspace.Exposure of l4-l5 intervertebral body space.

• 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: 5150838
• MDR Text Key: 28304216
• Report Number: 1030489-2015-02683
• 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
• Report Date: 12/01/2017

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: 7510600
• Device Lot Number: M115006AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2015
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided; 11/06/2017
• Supplement Dates FDA Received: 04/28/2016; 12/01/2017
• 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: 97