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 Ossification (1428); Nerve Damage (1979); Pain (1994); Disability (2371)

Event Type  Injury  

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.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) 2008, patient presented with following pre-op diagnosis: degenerative disk disease, l4-l5 and l5-s1.For which, patient underwent following procedures, anterior diskectomy and fusion, l4-l5 and l5-s1, with presacral approach with a posterior decompression, right, bilateral l5-s1 and a right l5-s1 facetectomy, posterior pedicle screw fusion on the right l4, l5 and s1 with intertransverse fusion on the right and removal of right-sided l3-l4 pedicle screws.Per op notes, at l5-s1, surgeon packed circumferentially four bmp sponges and then approximately 15 ml of bone void filler granules soaked in patient¿s bone marrow aspirate from sacral channel.Once complete exenterating of the disk was performed at the l4-l5 level, the disk was packed with four bmp sponges radially and another almost 15 ml of bone void filler-soaked bone.Patient tolerated the procedure well without any intraoperative complications.Patient's post-operative period was marked by a period of relief followed by prominent bone spurring and ossification in her lumbar spine.Patient continues to experience severe and unrelenting back pain, nerve damage, uncontrolled bone growth and permanent disability.This prevents her from practicing and fully enjoying the activities of daily life to the extent patient did preoperatively.

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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6394425
• MDR Text Key: 69555807
• Report Number: 1030489-2017-00511
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• 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: 02/13/2017

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: 05/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110610AAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: 02/13/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2007
• 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: 30 YR