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

Catalog Number 7510100

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

Patient Problem Disability (2371)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of 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) 2011: the patient was pre-operatively diagnosed with : l3-l4 and l4-l5 severe spondylosis with refractory axial and radicular back pain.Lumbar 3-5 spondylosis and foraminal stenosis with compression of the nerve root and underwent the following procedures: l3-l4 and l4-l5 direct lateral extra cavity discectomy and interbody fusion using peek, rhbmp-2/acs and putty (rattlesnake-eminent spine).Bilateral l3,l4 and l5 posterior spinal fusion using pedicle screws and rods.Laminectomy, lumbar, anterior/c ssep.As per the operative notes: ¿ an 8 x 22 mm peek interbody spacer was malleted into the l3-l4 disk space.In similar fashion, the l4-l5 disk space was identified and once again whatever little remnant disk material was removed in this area.A 10 mm tls cage was malleted into this l4-l5 region.The bigger dlif cage would not fit in the space.Once both implants were in proper position as confirmed by fluoroscopy, hemostasis was obtained.¿ it was reported that the patient have been disabled since a spine implant date (b)(6) 2011.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6628998
• MDR Text Key: 77220714
• Report Number: 1030489-2017-01465
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00613994239525
• UDI-Public: 00613994239525
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2012
• Device Catalogue Number: 7510100
• Device Lot Number: M111105AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2011
• 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
• Patient Age: 49 YR