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 Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (revision surgery, persisting back pain).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.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.

Event Description

It was reported that on (b)(6) 2012, patient underwent spine fusion surgery on the lumbar region from vertebrae l4 to l5.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and posterolateral gutters).Allegedly, patient's post-operative period was marked by a period of improvement, followed by followed by escalating low back pain and radicular pain in his right lower extremity.Severe pain and symptoms ultimately compelled patient to undergo a painful revision surgery on (b)(6) 2014.Patient continues to experience chronic lower back pain, pain radiating to his right leg and foot, and tingling and numbness in his right ankle and foot.Patient was experiencing difficulty in sitting and walking for extended periods, and must use a walking stick to assist in stability.Patient also suffers from bowel dysfunction.These serious injuries prevent patient from practicing and enjoying the activities of daily life that he enjoyed pre-operatively.

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.

Manufacturer Narrative

Mentioned device with quantity of 2 was used in the event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6)2012: the patient was pre-operatively diagnosed with recurrent herniated nucleus pulposus with stenosis, l4-l5 and underwent the following procedures: 1) right transfacet decompression, l4-l5, with revision discectomy laminoforaminotomy, l4-l5.2) minimally invasive transforaminal lumbar interbody fusion, l4-l5, using peek prosthetic interbody device, allograft and autograft.3) bilateral titanium pedicle screw instrumentation, l4-l5.4) posterolateral arthrodesis, l4-l5.As per op-notes,¿ this bone graft was later used for bone graft purposes.The la nerve root was dearly identified and displaced from this large recurrent disk herniation.This was also confirmed with his preoperative mri.Several large additional fragments of disk were removed.Of note, the annulotomy defect from the herniations was quite large, measuring greater than 1 cm.This completed the diskectomy portion, as well as the revision laminofaraminotomy.The la nerve was fully decompressed in this transfacet manner.Next, remaining spondylitic disk was removed.The endplates were then prepared.The appropriate dilators for the peek cage were chosen.The final implant size was 13 height, 30 in length.Prior to placement of the implant, allograft was packed anteriorly on the anterior annulus.This was fallowed by placement of the cage through the annulotomy.This was rotated 90 degrees to set in its final resting position at the l4-l5 level.Pedicle screws were then placed via the retractor system bilaterally.These were 6.5 x 40 screws.The screws had excellent purchase.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6207970
• MDR Text Key: 63359134
• Report Number: 1030489-2016-03536
• 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,Followup
• Report Date: 01/26/2018

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: 08/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111104AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 01/08/2018
• Supplement Dates FDA Received: 09/27/2017; 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2011
• 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