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

Catalog Number 7510800

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

Patient Problems Syncope (1610); Fatigue (1849); Fever (1858); Headache (1880); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Chills (2191); Dizziness (2194); Hernia (2240); Sore Throat (2396); Loss of consciousness (2418); Neck Pain (2433); Breast Mass (2439); Sleep Dysfunction (2517); Disc Impingement (2655)

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.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 : per medical records (b)(6) 2010, patient underwent cervical vertebrectomy c4-5, partial vertebrectomy c3 and 6, cervical fusion with plate c3 and 6, end plate decortication and cages c3-6.(b)(6) 2010, patient presented for f/u back surgery.(b)(6) 2010, patient presented for follow up of cervical spine lf performed on (b)(6) 2010; (b)(6) 2011, patient visited for f/u.Diagnosis stated cervical radiculitis.(b)(6) 2011, the patient presented for follow up and evaluation result of mri-cervical.(b)(6) 2011, patient presented with cervicalgia and underwent pre-operative examination and lab test (complete blood count, urinalysis , routine microbiology).Radiological study revealed normal two view chest.(b)(6) 2011, the patient presented with the following pre-op diagnosis: status post anterior c3 to c6 fusion and decompression for epidural abscess.He underwent the following procedures: posterior cervical fusion c3-c4, c4-c5, c5-c6.Posterior cervical instrumentation with lateral mass screw right and left c3, right and left c4, right and left c5, and right and left c6.Left-sided c5-c6 foraminotomy.Use of rhbmp/2 and some graft matrix.Per op notes, a left-sided inferior aspect of c5 and superior aspect of c6 was thinned with a bur and then taken down with #1 kerrison.This was done until a woodson could be easily placed into the left c5-c6 foramen.Once this was done the rods were placed and the caps were placed and sheared off.The lateral mass was packed with bmp and some graft matrix.Subsequently, the fascia was closed with ethibond and then the drain was placed and then skin was closed with 2- vicryl and nylon.(xray ) impression: operative fusion of the lower cervical spine.Patient was discharged on (b)(6) 2011, the patient presented for f/u and (b)(6) abscess under chin.(b)(6) 2011, patient visited for f/u status post spine surgery, refill and due to neck pain and (b)(6) abscess under chin.Diagnosis stated cervical radiculitis; cervical disc herniation; post-operative care in global.(b)(6) 2011, patient presented for f/u neck pain /back pain and (b)(6) abscess under chin.Per medical records, he is experiencing chronic pain, swelling, cervical pain all along neck and head.Assessment:- healed abscess under right chin.He also needed medicine refill for his pain.Also ordered for radiology test.(b)(6) 2011, patient presented for medicine refill and cervical disc with myelopathy.His neck pain was radiating into left arm and leading to weakness.(b)(6) 2011, patient presented for suture removal.X ray exam of neck spine.(b)(6) 2011, patient presented for f/u.His x-rays show instrumentation to be in good position without any evidence of loosening.(b)(6) 2011, patient presented for evaluation of his groin after he slipped and fell while walking down the stairs.He underwent physical, radiological examinations.(b)(6) 2011, the patient presented for f/u of pain management.Musculoskeletal study indicated cervical spine pain.(b)(6) 2011, the patient presented for f/u of pain management.Genitourinary indicated inguinal canal positive for tenderness on the right.Musculoskeletal indicated left shoulder had tenderness.(b)(6) 2011, patient presented for evaluation and treat right inguinal hernia (b)(6) 2011, patient presented for evaluation prior to surgical repair of left inguinal hernia.Underwent hematology examination which included cbc; chemistry test, ecg.(b)(6) 2012 , patient presented for refill of pain medicine and results of stress test.Pt was here status post r inguinal hernia repair, and he had multiple staple scars from where these staples were removed that are healing well.(b)(6) 2012 , patient presented with headache, anxiety and for medicine refill.(b)(6) 2012, the patient presented for f/u of pain, insomnia.Sleep disturbances and suicidal ideation, dizziness, dysarthria, headache, loss of consciousness and syncope.(b)(6) 2012, patient presented for neck pain assessment.His examination indicated following symptoms extremity, anxiety, depression, and insomnia.(b)(6) 2012, patient presented with pain and breast lump.The mass was described as smooth, firm and mobile.(b)(6) 2012, patient presented for f/u of her lump found in his right breast.Ultrasound shows a mass of 2cmm in diameter.Assessment: diagnostic testing revealed that the mass had not changed since its initial presence.Pain had been stable.(b)(6) 2012, patient presented for cough and neck pain.(b)(6) 2012, patient presented for medicine refill and to know results of his biopsy.The right breast mass was reported as angioglioma (b)(6) 2012 ; (b)(6) 2013 , patient presented for follow up of back pain and chronic neck pain.He needed medicine refill and was recommended for physical therapy.(b)(6) 2013, patient presented with diabetes, htn and neck pain.He underwent physical examination.(b)(6) 2013, the patient presented for radiculitis thoracic /lumbar.Patient was advised for mri.His medicine was refilled for neck pain.(b)(6) 2013, the patient presented for evaluation of erectile dysfunction and refill of medicine.Patient was sent for new mri of lumbar spine to look at any new impingement that may be causing this erectile dysfunction.(b)(6) 2013, patient presented with multiple issues - chronic pain, anxiety, swelling in his neck.He was refilled pain medication.(b)(6) 2013, patient presented for monthly visit.Pain is unchanged and unable to take proper sleep.Ecg was performed.(b)(6) 2013, patient presented for renew of his medicines.Referred for radiology, diagnostic testing.(b)(6) 2013, patient presented for check-up and medicine refill.No change in his pain conditions.(b)(6) 2013, patient presented with cold symptoms - chill, fatigue, fever, nasal congestion, post nasal drainage, sore throat.(b)(6) 2014, the patient presented for f/u of pain management - joint pain and neck pain.Patient was refilled with medicine.

• 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: 5076931
• MDR Text Key: 25777791
• Report Number: 1030489-2015-02359
• 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
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M110916AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2010
• 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: 98