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 Unspecified Infection (1930); Pain (1994); Seroma (2069)

Event Type  Injury  

Event Description

It was reported that the patient requested hardware removal.Patient has done very well from his decompressive laminectomy and fusion.Radicular symptoms have improved and his back pain is much better, but he still has pain and stiffness in his back which he related to his instrumentation.Patient underwent: removal of hardware through sacrum with exploration of fusion; redo-lumbar fusion l4-l5 with posterolateral bony fusion using harvested iliac bone graft augmented with rhbmp-2/acs and allograft; redo instrumentation fusion l4-l5 with implantable instrumentation; and harvest of iliac one graft from the left hip.(b)(6) 2006 - patient report some back pain, basically comes on when he bends over to pick up some weeds or is doing much in the way of activity.Overall, he is better after his lumbar fusion.Before that he hurt all the time and he had lumbar radiculopathy.(b)(6) 2007 - mri results show small fluid collection is present in the laminectomy site dorsal to the thecal sea, it shows mild peripheral enhancement.It may represent a seroma, hematoma or csf collection.Presence of infection does not appear particularly likely but cannot be fully excluded.Granulation tissue is noted dorsal to the thecal sac and contacts both the posterior aspect of l5 roots as well as the s1 fairly well decompressed at l4-l5 status post fusion.Early central canal stenosis is present at l3-4 as a result of congenital and acquired factors.(b)(6) 2007 - increased low back pain after slipping on water and falling on the part of his back from his first surgery.(b)(6) 2007 - patient reported falling at store and has some increasing back pain.He has a fluid collection which is persistent since his surgery.Everything else looks to be in good position.(b)(6) 2007 - low back continued to be quite painful since the fall.He has completed physical therapy over the summer which did not help.Mri shows a central herniated disc, lateral recess stenosis and facet hypertrophy; he may do well with further decompression and extension of his fusion in the future.(b)(6) 2008 - patient had increasing pain down his left side.He has pain with walking but is really just not concentrating on it as much.He reports pain into his left groin and posterolateral thigh stopping at mid calf.

Manufacturer Narrative

Concomitant medical products: implantable instrumentation (implant: (b)(6) 2005.(b)(4).

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4246789
• MDR Text Key: 5051936
• Report Number: 1030489-2014-04383
• 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: 10/13/2014

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: 7510800
• Device Lot Number: M115004AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 11/12/2014
• 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): Required Intervention
• Patient Weight: 107