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 Incontinence (1928); Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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) 2008, the patient underwent lumbar fusion at levels l4-5 wherein (b)(4) was implanted.Post-op, the patient had increasingly severe low back pain and radiculopathy into his lower extremities.The patient continued to experience chronic low back pain, with pain radiating to his left hip and buttocks.He is unable to stand for extended periods, and also suffers from urinary incontinence and sexual dysfunction.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2008: the patient was pre-operatively diagnosed with l4-l5 degenerative disc disease chronic back pain.Positive discography and underwent the following procedures: complete lumbar discectomy at l4-5 anterior lumbar interbody fusion l4-l5, utilizing structural allograft, packed with bmp sponge and demineralized bone matrix, fixed anteriorly with four hole anterior tension band plate.As per op-notes,¿ i elected to go with the structural 13 millimeter structural femoral ring allograft.We thawed it, as it was fresh frozen.We put a bmp sponge in their, as well as demineralized bone matrix and used the squid to seat it into the disc space and then impactedit and recessed it posteriorly.We checked with fluoroscopy.Then we placed a four hole anterior tension band, lumbar plate, with 26 millimeter screws in 4 and 5.X-rays were anatomic.¿ 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: 5543616
• MDR Text Key: 41720375
• Report Number: 1030489-2016-00909
• 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: 12/22/2017

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: 10/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110706AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 12/04/2017
• Supplement Dates FDA Received: 09/20/2017; 12/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2008
• 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): Other