MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); No Code Available (3191)

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) 2014, patient underwent following procedure, anterior fusion l2-3, l3-4.Implantation of cage, l2-3, l3-4.Bone grafting pre-op and post-op diagnosis:.Lumbar pseudoarthrosis l3-l4, l5-s1.Lumbar spinal stenosis l2-l3, l3-l4.Status post l3 to s1 fusion.History of tobacco use.Indications: patient with ongoing back and some leg pain who has undergone multiple previous lumbar spinal decompression and fusion procedures.Patient has developed pseudoarthrosis.As per operative notes: ¿.A 10-mm trial was impacted in position and neurological monitoring remained intact.Ap and lateral fluoroscopic views revealed excellent position of the kit trial.The trial was withdrawn, the wound was irrigated and meticulous attention was then paid to preparing the endplates for arthrodesis.At this juncture, the introductory slides were placed into the disk space.The cage was packed with bone graft materials.It was impacted in position.Once the cage was in excellent position in ap and lateral fluoroscopic views, the introductory slides were removed.At l3-4, the endplates were meticulously prepared, initial trial was placed.This was an 8-mm trial, it was too small.A 1 0-mm trial was also judged to be too small.The 12 mm trial, however, gave excellent stability.This was 12 mm parallel cage.The wound was once again copiously irrigated and care was taken to ensure the endplates were meticulously prepared.The 12-mm cage was filled with bone graft and then the introductory slides were placed into the cage, into the space.No complications were reported.¿ post-operatively the patient was diagnosed with stenosis and non union due to which the patient underwent revision surgery.

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: 6299106
• MDR Text Key: 66429712
• Report Number: 1030489-2017-00208
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• 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