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 Neuropathy (1983); Pain (1994); Distress (2329); Nerve Proximity Nos (Not Otherwise Specified) (2647)

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 underwent the following procedures: posterior spinal fusion, 3-4 and l4-5, exploration of fusion l4-l5, segmental instrumentation l3-l5, removal of hardware at l4-l5 to treat the following pre-op diagnosis: herniated disk, l4-l5 status post fusion, possible pseudoarthrosis l4-l5, transition syndrome l3-4 with bulging disk.Post-op diagnosis: herniated disk, l4-l5 status post fusion, possible pseudoarthrosis l4-l5, transition syndrome l3-4 with bulging disk, pseudoarthrosis l4-l5.Intraoperative findings: ".He was noted to have loose hardware at the l4-l5 level and motion and the l4-l5 consistent with pseudoarthrosis."operative notes: ".Morcellized autograft as well as bone graft with rhbmp-2/acs sponge.One large kit was placed in the posterolateral gutters bilaterally.7.5 pedicle screws were then placed at l4 and l5 bilaterally.Screws were independent stimulated and found to have good impedance.Two long rods were applied to the pedicle screws and secured." the patient was returned to the supine position, awakened, extubated and transferred to the recovery room having tolerated the above procedure well and in stable condition.

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: 5596958
• MDR Text Key: 43270729
• Report Number: 1030489-2016-01160
• 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: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2012
• Device Catalogue Number: 7510800
• Device Lot Number: M110809AAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2009
• 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