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 Stenosis (2263); Arachnoiditis, Spinal (2390); Post Operative Wound Infection (2446); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) 2010: the patient underwent mri of lumbar spine post contrast.Impression: limited study due to technical artifacts from metallic surgical hardware.Centered at the l3 level is a deep dorsal large fluid collection with greatest dimensions 5.2 x 2.0 x estimated 9.6 cm (axial x cc).Any infection of this postoperative fluid collection can not be excluded by mri modality alone.Adjacent to bilateral l5-s1 facet joints are separate fluid collections, 2 cm approximately.New from 2008 study is decreased t1 and increased t2 signal intensity with enhancement in the l5 vertebral body and moderately at s1 (sacrum).Findings are very worrisome for osteomyelitis.New since 2008 study is moderate anterior collapse/compression fracture of the l5 vertebral body.New strut bone graft extends through the l3 vertebral body and it involves both adjacent disc spaces.New fluid in the l3-4 disc space is uncertain if corresponding to postoperative changes or possible discitis.New from 2008, dorsal fusion hardware now extends from the l5 level to l1.Multilevel degenerative disc disease.Visualization of neural foramina is limited due to adjacent metallic surgical hardware.Replacement of anatomic fat in bilateral neural foramina at l3-4 is suggestive of edema.

• 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: 5158619
• MDR Text Key: 28586854
• Report Number: 1030489-2015-02722
• 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: 09/28/2015

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 Expiration Date: 12/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110809AAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2009
• 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): Required Intervention
• Patient Weight: 64