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); Post Operative Wound Infection (2446); 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) 2013, patient underwent following procedure, removal of hardware, bilateral l4, l5, s1.Exploration of fusion l4-l5, l5-s1.L3 laminectomy with decompression of canal and nerve roots.Bilateral foraminotomies, l3, l4 with lysis of adhesions at l3-l4 junction.Bilateral l3-l4 facetectomy.Revision posterolateral fusion l4-l5, l5-s1 with extension fusion to l3 using bmp harvest local bone graft and bone marrow aspirate.Aspiration of ilium for bone marrow aspirate to be used in posterolateral fusion mass.Pedicle screw instrumentation, bilateral l4-l5, 7.5 x 45-mm, right s1 8.5 x 30 rom, left s1 10 x 40-mm, crosslink placed between l5 and s1.Pre-op and post-op diagnosis, status post l4-l5, l5-s1 posterolateral fusion with pedicle screw instrumentation.Pseudoarthrosis l4-l5, l5-s1.Per operative notes, ¿.The bony margins were then exposed from the l2-l3 facet, through the l3 pars, and residual transverse process, bilateral l4-l5, as well as the upper portion of the sacral ala in anticipation of revision fusion.The ilium was aspirated for bone marrow to be used in the posterolateral fusion mass consisting of bmp, and harvest local bone graft and bone marrow aspirate.She was transferred to the recovery room in stable hemodynamic and neurologic condition." post-operatively the patient was diagnosed with stenosis and non union due to which the patient underwent revision surgery.On (b)(6) 2013, patient underwent following procedure: incision and drainage of lumbar wound.Pre-op and post-op diagnosis: lumbar wound infection.No complications were reported.

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: 6299101
• MDR Text Key: 66433283
• Report Number: 1030489-2017-00202
• 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