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 Bone Fracture(s) (1870); Headache (1880); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Scarring (2061); Stenosis (2263); Injury (2348); Arachnoiditis, Spinal (2390); Neck Pain (2433); Sleep Dysfunction (2517); Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Location : hospital.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) 2006: patient presented with pre-op diagnosis: l5-s1 advanced degenerative disk disease and stenosis.Procedure: 1) l5-s1 bilateral laminectomies and foraminotomies.2) l5-s1 posterior lumbar interbody fusion after complete discectomy.3) use of the cages in the interbody space.4) use of iliac crest bone graft in the interbody space at l5-s1.5) posterior spinal arthrodesis at l5-s1 6) use of legacy pedicle screw and rod system posteriorly at l5-s1.7) use of iliac crest bone graft posterolaterally in the lateral gutters.Procedure: all four bony elements were decorticated and then inserted four pedicle screws.Two cages were packed with iliac crest bone autograft, and then appropriately sized rods were placed over the pedicle screws on the both sides.Stable condition.Intraoperative lateral x-rays were taken.Conclusion: 1) initial intraoperative localization l5-s1 disk space.2) posterior fixation interconnecting rods and disk fusion in satisfactory alignment l5-s1.Patient alleges injuries due to rhbmp-2/acs.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2006 patient presented for er xr ribs unilateral lt.Impression: fracture left ninth rib.(b)(6) 2006: patient underwent mri of lumbar spine unenhanced.Impression: annular fissure, posterior margin of l3/4 disc.Degenerative disc disease l3/4, l4/5 and l5/s1.Most marked at the 5/1 level.Moderate central soft disc bulge, impacting forming right s1 nerve root at the l5/s1.(b)(6) 2006: patient visited the facility for follow up due to back and leg pain.(b)(6) 2006 patient presented for ct abdomen contrast.Impression: 1.Surgical clips in the mid and lower abdomen.The stomach was in completely distended for proper evaluation.(b)(6) 2006 patient presented for cervical, chest and left shoulder x-ray.Impression: 1) no fracture or dislocation.Impression: 1.No acute infiltrate or pleural effusion.2.Normal heart size.3.No pneumothorax or mediastinal widening.Impression: 1) no fracture or disloc.(b)(6) 2007 patient present for er xr cervical spine 7 views.(b)(6) 2007: patient presented with sleep apnea.(b)(6) 2007: the patient underwent ct of lumbar spine.Impression: broad based disc bulge l4-5 with distortion of the left lateral recess and severe narrowing of the left lateral neural foramen.(b)(6) 2008: patient presented with back and leg pain radiating to feet.(b)(6) 2008 patient presented for er xr chest pa and lat.Impression: 1.Scarring and/or atelectasis left base.No active cardiopulmonary disease is seen.(b)(6) 2008 patient presented for cervical spine.Impression: 1.Normal cervical spine.(b)(6) 2008: the patient underwent lumbar spine myelogram.Impression: no evidence of severe central or lateral stenosis.(b)(6) 2008: patient presented with lower backpain (b)(6) 2008: the patient underwent lateral lumbar spine x-ray.Impression: there are now interpedicular screws at l4 and l5.There is a cage with bone graft in the disc at l5-s1.The screws have been removed from l5-s1.History of bone graft material is also noted.There is surgical clips in the pelvis.There is a bullet fragment ventral in the sacrum at the l3-4 level.(b)(6) 2009: patient underwent right shoulder 4 views.Impression: normal right shoulder.(b)(6) 2009: patient presented with following preop diagnosis: full thickness rotator cuff tear right shoulder with subacromial impingement.Procedure: open arthroscopy with minor debridement labral tissue.Open rotator cuff repair, acute, subacromial decompression acromioplasty with bursectomy and coracoacromial ligament release.(b)(6) 2009: patient presented with right shoulder pain.(b)(6) 2010 patient presented with left flank and left sided abdominal pain.Patient presented for er xr abdominal series.Impression : no acute cardiopulmonary or abdominal findings.(b)(6) 2010 patient presented for er xr hand right: conclusion: 1.Acute fracture proximal phalanx.Suspect old, fracture mid phalanx, but with deformity and arthritic changes proximal interphalangeal-joint.(b)(6) 2010 patient presented with hand injury (b)(6) 2010 patient presented for ct renal stone (noncontrast abdomen and pelvis ct).Impression: 1.No acute obstructive uropathy.2.Small gallstone.3.Grade ii anterolisthesis l4 on l5 with possible loosening around the l4 pedicle screws.(b)(6) 2011: patient got admitted in the facility for some tests.(b)(6) 2011: patient presented with left side pain, trouble swallowing.(b)(6) 2012: patient presented with anterior shoulder at bicipital groove area and also in lateral upper arms.Stabbing aching pain.(b)(6) 2015 patient for presented for "er xr chest pa and lat".Impression: unremarkable chest.(b)(6) 2015 patient for presented for "er xr lumbosacral spine ap and lat".Impression: 1.No acute findings.2.Intact posterior fixation hardware.3.Grade 2 anterolisthesis l4 on l5.(b)(6) 2015 the patient was diagnosed for lumbago, pain in soft tissue of limb.(b)(6) 2015 the patient was diagnosed for pain in joint, shoulder region.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2013, the patient presented for follow up of posterior tibial nerve block.Assessment : diabetic peripheral neuropathy and bilateral foot pain.On (b)(6) 2013, the patient presented for follow up regarding evaluation and treatment of the neuropathic pain.On (b)(6) 2013, the patient presented with pre-op diagnosis of small fiber neuropathy and extremity pain and underwent treatment of small fiber neuropathy (b)(6) 2015 the patient was presented for office visit with low back pain, bilateral lower extremity pain.On (b)(6) 2015 the patient was presented for office visit with neck and shoulder pain.The patient also underwent x rays of the cervical spine and shoulders.There was some ac and glenohumeral arthritis in the left shoulder.In the right shoulder again there was a little bit of glenohumeral degeneration and ac arthritis.The lateral cervical spine shows decreased lordosis with age appropriate degenerative change but no significant malalignment.On (b)(6) 2015 the patient was presented for office visit with low back pain and lower extremity pain anterior into his feet.Assessments: low back pain with bilateral anterior lower extremity pain that radiates into both feet, worsened with a head on collision on (b)(6) 2015 and then when he fell into a hole at a car wash later in (b)(6) of 2015.On (b)(6) 2015: the patient presented for a follow up.On (b)(6) 2015 the patient was presented for office visit with left shoulder pain and right shoulder pain.On (b)(6) 2015 the patient was presented for office visit with low back pain.Mri studies were reviewed.They do show the hardware previously placed at l4-5.They are still well positioned.He still has spondylolisthesis at this level, but there seems to be fusion here.On (b)(6) 2015 the patient was presented for office visit with bilateral shoulder 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: 5108240
• MDR Text Key: 26904656
• Report Number: 1030489-2015-02506
• 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: Followup,Followup,Followup,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• 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: M115007AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2016
• 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): Required Intervention
• Patient Age: 00046 YR
• Patient Weight: 95