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 Wound Dehiscence (1154); Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

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: (b)(6) 2008, the patient presented with following pre-operative diagnosis: non union l5-s1; low back pain ; lumbar radiculitis and underwent following operations: revision decompression l5-s1 bilateral ; revision posterior spinal instrumentation l4 to pelvis ; posterior spinal fusion l4-s1 using local bone graft , morsellized allograft optium putty and bmp ; tlif l5-s1 using structural cages , bone graft and bmp ; anterior spinal osteotomy l5-s1.Per op-notes, ".A harms cage was filled with a bmp soaked collagen sponge and placed in on the left side and rolled over to the right side.Finally a second cage was filled with morselized allograft optium putty and placed in on the left side." next on the right side of the fusion mass at l4-5 was decorticated as was the remnant of the l5-s1 facet, pars and sacral ala.A bmp soaked collagen sponge was then wrapped around graft crystals creating a burrito ".(b)(6) 2013, the patient presented with pre-op diagnosis of post laminectomy syndrome and underwent following procedure: removal of spinal hardware ( lumbar pedicle screw instrumentation , iliac bolt , wing instrumentation ) ; revision laminectomy posterior lumbar with fusion ; foraminotomies , exploration of fusion , possible re-fusion , if needed, cellsaver.Per op notes, ".Area of the seroma cavity was encountered until the rods and the connection between the two pedicle screw instrumentation with the relevant instrumentation.Two were sequentially then disabled and removed."(b)(6) 2013, the patient presented with pre-op diagnosis of posterior lumbar spinal wound dehiscence and possible infection and underwent following operations: irrigation and debridement , posterior spinal wound ; wound closure for treatment of wound dehiscence.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5646179
• MDR Text Key: 44886522
• Report Number: 1030489-2016-01352
• 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,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• 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