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

Catalog Number 7510600

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

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2007 the patient underwent an exploration and anterior lumbar decompression necessitating partial corpectomy at l3-l4 using rhbmp-2/acs, allograft and interbody cage.It was reported that on (b)(6) 2007, patient underwent a cervical surgery due to the diagnosed disc herniations at c4-5 and c5-6.During this surgery, doctor removed the anterior cervical plate from a prior fusion and the fusion was confirmed.Doctor then performed partial corpectomies c4, c5, and c6 followed by an anterior cervical fusion c4-5, and c5-6, using interbody cage with allograft bone.Subsequently, doctor diagnosed the patient with pseudoarthrosis at l3-l4 and lateral recess stenosis at l3-l4.On (b)(6) 2009 patient underwent an additional operation on his lumbar spine.During this operation, doctor performed a bilateral l3-l4 revision hemilaminectomy with partial foraminotomy and facetectomy, a bilateral fusion at l3-l4, and insertion of k2m spinal instrumentation at l3-4 using local bone and allograft bone.As a result, patient has never fully recovered from these spinal surgeries and continues to suffer from daily severe and disabling pain in his back and neck, numbness and pain in his legs, swallowing and choking issues, a raspy voice and coughing, and a visible shift in his spine to the left.

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

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

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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3663942
• MDR Text Key: 4341696
• Report Number: 1030489-2014-01670
• 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,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2009
• Device Catalogue Number: 7510600
• Device Lot Number: M110601AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2006
• 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: 00055 YR