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 Fatigue (1849); Headache (1880); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Sprain (2083); Swelling (2091); Sneezing (2251); Stenosis (2263); Depression (2361); Inadequate Pain Relief (2388); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that the patient again underwent fusion of lumbar spine at levels l2-l3 using rhbmp-2/acs, which was places in posterior elements outside a cage from a posterior approach.Post-op, the patient continued to experience severe and chronic lower back pain, with pain and radiculopathy in her lower extremities.She was very limited in her movements and activities and required occasional use of a cane to assist in ambulation.

Event Description

It was reported that on (b)(6) 2010: patient presented with the following pre-op diagnosis: lumbar pain.Lumbar radiculitis.Lumbar 2-3 postoperative seroma.Procedure: lumbar 2-3 evacuation of superficial seroma and deep hematoma.Lumbar 2-3 hardware removal.Lumbar 2-3 posterior fusion.Lumbar 2-3 posterior instrumentation.Per op-notes: the old sutures were removed, the fascial sutures were removed, and surgeons placed a gelpi, exposing the plate and the deeper cage.Bone cage was replaced in addition to the new posterior clamp for the hardware fixation from l2-3.Patient was presented with pain on the right.Medium tlif plate in addition to small bmp kit was used.

Event Description

It was reported that on: (b)(6) 2010, (b)(6) 2014, (b)(6) 2016: the patient underwent study of bone densitometry.On (b)(6) 2014: the patient underwent radiologic study of thoracic spine due to indication of height and weight loss.Impression: stable scoliosis.Tiny osteophytes.Minor degenerative changes.The patient also underwent radiologic study of lumbar spine due to previous study.Impression: post-surgical and minor degenerative changes.

Event Description

It was reported that on, (b)(6) 2010, (b)(6) 2014, (b)(6) 2016: the patient underwent study of bone densitometry.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012: the patient presented for evaluation of a scaly lesion.On (b)(6) 2010: the patient presented with a concern of neoplasm on l hand also with new scaly red spots exam showed scaly erythematous macules on left forearm.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: the patient presented with skin growth, history of nonmelanoma skin cancer, actinic keratosis, lentigo simplex.On (b)(6) 2014: the patient underwent radiologic study of thoracic spine due to indication of height and weight loss.Impression: stable scoliosis.Tiny osteophytes.Minor degenerative changes.The patient also underwent radiologic study of lumbar spine due to previous study.Impression: post-surgical and minor degenerative changes.On (b)(6) 2015, (b)(6) 2016: the patient presented for follow up exam for skin cancer.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2010: patient was diagnosed with lumbar hematoma and stenosis.Patient underwent revision of lumbar 2-3 foraminal decompression with hardware removal and subsequent revision of posterior fusion and instrumentation.Per-op notes: ¿she was taken to the or on the day of her admission.A subcutaneous seroma was noted.Some residual foraminal stenosis and a hematoma were both noted.I am suspicious that she had some of the bone morphogenic protein infiltrating the hematoma contributing to the neural inflammation.She tolerated the procedure well.¿¿ on (b)(6) 2010: patient presented for a follow-up visit post an l2-3 decompression and ilif.Patient underwent a physical exam and x-ray.Impressions: no evidence of loosening or failure of her hardware.On (b)(6) 2010: patient presented for a follow-up visit due to swelling over the incision area and increasing pain in the back.On (b)(6) 2010: patient presented for a folklow-up visit post surgery.Impressions: doing well status post an interlaminar interbody fusion.On (b)(6) 2011: patient underwent a ilif at l2-3 due to pain at right low back, buttock and thigh pain.

Manufacturer Narrative

Additional information: describe event or problem, relevant tests/lab data, model #/lot #, (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) 2010: patient underwent lateral and right and left oblique images of cervical spine due to chronic neck pain.Impression: stable cervical spine radiographs.(b)(6) 2010 the patient presented for office visit with chronic cervical pain and right shoulder pain.She reported that headaches, muscle tightness, bladder infection.Impression: chronic right shoulder pain with shoulder impingement syndrome.Chronic cervical pain status post fusion with history of herniated disc.Exacerbated due to spasms.Depression.On (b)(6) 2010, (b)(6) 2011 the patient presented for office visit with chronic cervical pain, right shoulder pain and history of insomnia.She had mild constipation.Impression: chronic right shoulder pain with shoulder impingement syndrome.Mild exacerbation.Chronic cervical pain status post fusion and history of herniated disc.Insomnia.(b)(6) 2011, (b)(6) 2012 the patient was presented for office visit with chronic cervical pain and chronic shoulder pain.Increased cervical pain associated in increased headache that starts at the back of her neck radiating up.Impression: chronic right shoulder pain with shoulder impingement syndrome with mild exacerbation.Chronic cervical pain status post fusion with headache.On (b)(6) 2012 the patient presented for office visit with chronic cervical pain and right shoulder pain.She described mild increase of her pain but attributed this to having some allergies and coughing and sneezing of recent.Impression: chronic cervical pain status post fusion.Mild exacerbation due to her sinuses.Chronic right shoulder pain with shoulder impingement syndrome.Mild exacerbation due to due to spasms.On (b)(6) 2012 the patient presented for office visit with shoulder pain, cervical pain with associated headaches.The patient reported that pain radiating forward and when becoming severe are associated with nausea and photophobia and phonophobia.Impression: chronic right shoulder pain with shoulder impingement syndrome.Chronic cervical pain status post fusion.Mild increase of her headaches.On (b)(6) 2012 the patient presented for office visit with fatigue, pain, constipation and sleep disturbances.Impression: chronic right shoulder pain with shoulder impingement syndrome.On (b)(6) 2012 the patient presented for office visit with shoulder pain and chronic cervical pain with associated headaches.Impression: chronic right shoulder pain with shoulder impingement syndrome.Chronic cervical pain status post fusion.On (b)(6) 2016: the patient underwent radiographic exams of lumbar spine due to chronic low back pain and prior lumbar surgery.Impression: no acute interval change.On (b)(6) 2016: patient presented with neck pain that radiates into the right arm and hand.Assessment: neck pain with cervical post laminectomy syndrome.Right shoulder pain with rotator cuff injury, stable.On (b)(6) 2016: patient underwent lumbar medial branch injections to lumbar facet joints: bilateral, fluoroscope-guided.On (b)(6) 2016: patient presented for radiology exam of ap lateral and patellar sunrise views bilateral knees due to pain.Conclusion: no plain film evidence of acute bony abnormality.Bilateral small knee effusions.Moderate bilateral arthrosis, right worse than left.On (b)(6) 2016: patient presented for a follow-up visit due to headaches and neck pain.Patient was examined.Impression: cervical postlaminectomy syndrome with cervicogenic/ migraine headaches.On (b)(6) 2016: patient presented with pre-op diagnosis: lumbar spondylosis.Back pain.Patient underwent radiofrequency ablation.No complications were reported as a result of the event.On (b)(6) 2016: patient underwent right l1, 2, 3 medial branch radiofrequency ablation (rfa).Impression: right inguinal and anterior t high pain.Onset one day after right l1-3 medial branch rfa.Differential diagnosis is neuropathic pain secondary to the radiofrequency versus meralgia paresthetica.On (b)(6) 2016: the patient underwent mri of the left knee without contrast due to diffuse knee pain around patella.Impression: the primary abnormality is osteoarthrosis in the patellofemoral joint and medial compartment.No definite meniscal tear.There is large joint effusion.On (b)(6) 2016: patient underwent chemodenervation muscle; muscle innervated by facial, trigeminal, cervical spine and accessory nerves, bilateral with botulinum toxin a.No image guidance.Patient also underwent left knee intra-articular injection due to left knee tricompartmental osteoarthritis.Patient tolerated the procedure well.

• 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: 5146731
• MDR Text Key: 28139474
• Report Number: 1030489-2015-02664
• 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,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2012
• Device Catalogue Number: 7510200
• Device Lot Number: M110805AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2009
• 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
• Patient Weight: 91