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 Ossification (1428); Anemia (1706); High Blood Pressure/ Hypertension (1908); Pain (1994); Stenosis (2263); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2003 the patient presented with persistent pain in the low back, radiating to the bilateral lower extremities, with numbness and tingling, worse with movement.Preoperative diagnosis: lumbar disk collapse, instability, lumbosacral level, with bilateral radiculopathy, positive discography at ls-s1.The following procedure were performed: 1.Muscle sparing anterior abdominal extra-peritoneal approach for anterior lumbar interbody fusion- 1level 2.Mobilization of the left iliac artery 3.Mobilization of the left iliac vein 4.Exposure of anterior surface of the spine.Per op notes the double barrel guide was inserted, the vascular was checked, and the two channels were then reamed and tapped and two 12 by 17 by 20 proximity cages were positioned with rh-bmp2/acs filling the cages.Additional rh-bmp2/acs was placed between and in the front of the cages.The vessels were checked.The guide was removed.The position of the cages was checked on x-ray and found to be satisfactory.(b)(6) 2011 the patient presented for office visit.Patient complained of cervicalgia and bilateral upper extremity numbness/paresthesia.(b)(6) 2011 the patient presented for the follow up.Patient's anemia of iron deficiency had resolved.(b)(6) 2011 the patient presented for the checkup.Diagnosis: cervical spinal cord stenosis/ bilateral cervical neural foraminal narrowing, overweight, hypertension, anemia from iron deficiency.(b)(6) the patient underwent ct of cervical with contrast.Impression: the ventral epidural soft tissue mass located posterior to c3 vertebral body is more conspicuous on the (b)(6) 2011 mri scan.It was thought to meet likely represent an extruded disc.(b)(6) 2011 the patient underwent mri of cervical spine.Impression: multilevel degenerative disc disease as detailed.The large ventral epidural soft tissue mass located posterior to the c3 vertebralbody, impinging upon the spinal cord, which is posteriorly displaced is thought to represent an extruded disc, from c3-4 level.There is associated moderate spinal canal stenosis.The patient underwent mri of shoulder: impression: 1.Supraspinatus tenderness with associated bursitis.2.Labral degeneration without discrete labral tears.(b)(6) 2012 the patient presented for the follow up.Diagnoses: overweight, other abnormal glucose, benign essential hypertension, routine gynecological examination, fibromyalgia.(b)(6) 2012 the patient underwent left flank soft tissue ultrasound.Impression: large 9.8 cm flank lipoma.(b)(6) 2012 the patient presented for the checkup.Patient lost some weight.The patient underwent pap smear.(b)(6) 2012 the patienttissue specimen was submitted for sigmoid poly biopsy.Microscopic: histologic section show a polypoid piece of coloric mucosa with hyperplastic.(b)(6) 2014 the patient presented for the follow up.The patient complained of low back pain and had back surgery 2003 and received a bone graft surgery, patient claimed for overgrowth of bone at the graft area.Diagnoses: benign essential hypertension, overweight, backache.(b)(6) 2014 the patient presented for the follow up.Patient had lost some weight and left lateral thoracic wall mass.Diagnosis: routine gynecological examination, other abnormal glucose, lipoma of breast.

• 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: 5052442
• MDR Text Key: 24928557
• Report Number: 1030489-2015-02189
• 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
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• 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: M0111004A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• 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: 107