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 Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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) 2010, the patient presented with pre-op diagnosis of synovial cyst; herniated disk; spinal stenosis at l4-5 ; grade i spondylolisthesis l4 on l5 with instability.Per op notes, the incision was made from l3 to sacrum.The l4 and l5 disk were identified and cleaned out.Mft bone dowel was sized to 13mm , packed with autograft bone and tapped into place and countersunk.Pedicles of l4 and l5 were cannulated with screws.They were connected with peek rods and locked into place.Posteolateral fusion was performed at l4 and l5.Lamina of l4 and l5 were completely removed.The interspace was packed and the bone was packed over the transverse processes with posteolateral fusion.Bone marrow aspiration was done through the pedicle screws at all 4 points to help develop a bone graft in the lateral gutters between l4 and l5.On (b)(6) 2010, the patient presented with pre-op diagnosis of lumbar disk syndrome at l4-5 and underwent following operating procedure ; posteolateral fusion at l4 <(>&<)> l5 , removal of posterior instrumentation at l4-5.Per op note, the left l5 screw appeared loose.All screws were removed.The screw holes were probed and bmp with sponge small fragment was placed in each screw hole followed by floseal.Lateral gutters were prepared and packed with wrapped in bmp, which was placed lateral gutters bilaterally.On (b)(6) 2010, the patient presented with pre-op diagnosis of presumptive wound infection in posterior lumbar incision for which the patient underwent incision and drainage of postoperative lumbar wound.On (b)(6) 2011, the patient presented with pre-op diagnosis; pseudoarthrosis, l4-5, status post prior left unilateral gill procedure with interbody fusion and pedicle fixation and s/p removal of previous instrumentation.The patient underwent procedure:- l4-5 secondary unilateral gill with placement of milled allograft interbody spacer and instrumented posteolateral arthrodesis at l4-5 utilizing pedicle screws and rods and intertransverse fusion utilizing strips.Per op note, the surgeon made incision and there was tremendous amount of scar tissue present over l4-5.Pedicle holes were drilled at l4 and l5.Screws were placed bilaterally at each level.The lateral edge of thecal sac was identified and origin of l4 and l5 nerve roots as well.The surgeon then entered insterspace and removed disk material.A single luminary spacer was selected.Center portion of spacer was filled with bmp sponge.The strips dipped in pedicle rich blood were placed in intratransverse space, completing the posteolateral arthrodesis.Screw heads were placed over the screws and rods were placed over screw head and tightened.

• 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: 5309539
• MDR Text Key: 33833524
• Report Number: 1030489-2015-03484
• 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: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Catalogue Number: 7510800
• Device Lot Number: M110909AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2010
• 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