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

Catalog Number 7510200

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

Patient Problems Pain (1994); Weakness (2145); Stenosis (2263); Ambulation Difficulties (2544); Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  Injury  

Event Description

It was reported that the patient underwent a spine fusion surgery on the lumbar region of his spine from l4 to l5 in which rhbmp-2/acs was used.Reportedly, the patient's post-operative period has been marked by increasingly severe right-sided pain and weakness in his lower back radiating into his right lower extremity.A ct scan taken (b)(6) 2008 reportedly indicated disc herniation and stenosis compressing his nerve roots at the level of his implant.It was reported that on (b)(6) 2011, the patient underwent a revision surgery on the lumbar region of his spine from l5 to s1 in which rhbmp-2/acs was used.An mri taken (b)(6) 2012 reveals recurrent spinal stenosis and disc bulges compressing the nerve roots at the levels of implant.Reportedly, patient continues to experience severe and unrelenting low back pain that radiates into his lower extremities and impedes his ability to ambulate, sit and stand.

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.

Manufacturer Narrative

Add'l info.

Event Description

It was reported that on: (b)(6) 2008, the patient was admitted to underwent procedure.(b)(6) 2008, the patient presented with pre-op diagnosis of 1) spinal stenosis l4-5.2) central disk herniation l4-5.3) right l5-s1 herniated disk 4) bilateral l4 spondylolysis without spondylolisthesis.The patient underwent following procedures : 1) partial laminectomy l3, l5.2)bilateral laminectomy l4.3) laminectomy and discectomy right l5-s1.4) posterior interbody fusion, l4-5.5) posterolateral fusion l4-5.6) insertion of tricortical allograft prostheses ,left l4-5.7) insertion of allograft cancellous bone chips and bmp.8) insertion of autograft bone and spinal instrumentation at l4-5.Per op notes, the surgeon cut a tricortical allograft prosthesis.They prepared crushed cancellous allograft bone chips which was mixed with bmp.The allograft chips and bmp was placed anterolaterally.The allograft prosthesis was placed and then posterior to this allograft bone and bmp was placed.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3963889
• MDR Text Key: 4560052
• Report Number: 1030489-2014-03334
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110703AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2008
• 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