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 Edema (1820); Pain (1994); Hernia (2240)

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, patient underwent bilateral groin exploration, plug and patch repair, for a pre-op diagnosis of bilateral inguinal hernias, query incarcerated left inguinal hernia.On (b)(6) 2003, patient reported back pain with right leg pain and some left leg pain.Mri scan showed: congenital stenosis involving l3-4 and l4-5 level.There is degenerative disc disease involving l4-5 along with a small disc herniation at this level.On (b)(6) 2003, patient presented for follow-up and reported back pain.Ct scan showed some leakage of dye along posterior aspect of disc at l4-5 level, but l3-4 and l5-s1 levels appear to be relatively normal.On (b)(6) 2003, patient underwent x-ray of chest.Impression: no radiographic abnormality identified.On (b)(6) 2003, patient reported severe back pain.On (b)(6) 2003, patient reported back pain and leg pain.Patient had a workplace injury while lifting pipes and he felt immediate back and right leg pain.Mri scan showed: congenital stenosis involving l3-4 and l4-5 level.There is degenerative disc disease involving l4-5 along with a small disc herniation at this level.On (b)(6) 2003, patient presented with severe back pain.Mri confirmed degeneration of l4-5 disc space.Patient underwent following procedure: l4-5 anterior lumbar diskectomy with interbody fusion.Use of lordotic 16mm cages filled with rh-bmp2/acs; for a pre-op diagnosis of l4-5 disc degeneration with spinal instability.Per-op notes: retroperitoneal exposure was performed and l4-5 disc was dissected and exposed.C-arm was used to identify center of disc.Disc was cleaned out and soft tissue was removed from within disc space.A 26 x 16 mm cage was filled with rh-bmp2/acs and screwed into place.Both cages were screwed in just posterior to anterior aspect of the vertebral body.No complications were reported during the procedure.On (b)(6) 2003, patient presented for follow-up.Patient reported dull aching sensation.On (b)(6) 2003, patient underwent x-ray of lumbar spine which showed cylindrical metal devices in the l4-5 interspace with good alignment.Clip anterior to the interspace from previous surgery.On (b)(6) 2003, patient presented for follow-up.Patient reported low back pain.X-rays revealed cages to be in good position.On (b)(6) 2003, patient presented for follow-up.Patient reported back pain on (b)(6) 2003, patient presented for office visit.Patient reported severe back pain and pain in anterior aspect of thigh.On (b)(6) 2003, patient underwent mri of lumbar spine with and without gandolinium.Impression: high signal bone marrow edema with enhancement of l4 and l5 vertebral body around the replaced disc space.Although infection could not be excluded, postsurgical changes and healing in the area could have similar appearance.Correlation with white cell count needed, fever as well as sed rate is needed.There is no evidence of recurrent disc herniation or free fragment in the area.On (b)(6) 2004, patient underwent incisional herniorrhaphy with mesh for a pre-op diagnosis of incisional hernia.

• 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: 5206948
• MDR Text Key: 30580896
• Report Number: 1030489-2015-02947
• 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: 10/26/2015

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: 7510400
• Device Lot Number: MC1114A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/06/2015
• 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