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 Unspecified Infection (1930); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that on (b)(6), 2012, the patient underwent a posterolateral fusion at l4-l5, l5-s1 using rhbmp-2/acs in multiple disc levels.Sometime postop, the patient began to experience increased back and bilateral leg pain.A ct-scan of the lumbar spine, performed on (b)(6), 2012, demonstrated that there was an abnormal lucency surrounding the left s1 pedicle screw, as well as lucencies within the end plates at the l4-l-5 level on either side of the disc space, which was indicative of subsidence.The patient continues to have daily severe disabling pain.

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

(b)(4).

Event Description

It was reported that on (b)(6) 2012, the patient underwent a transforaminal lumbar interbody fusion using rhbmp-2/acs.Post infuse surgery, the patient has been injured and suffers injuries to her body and mind.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient underwent three revision surgeries.Patient now has scoliosis and her left leg amputated.

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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3628412
• MDR Text Key: 4177760
• Report Number: 1030489-2014-00480
• 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,Followup
• Report Date: 02/10/2017

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: 08/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111101AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/10/2017
• Supplement Dates FDA Received: 12/19/2016; 02/27/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2011
• 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; Required Intervention
• Patient Age: 48 YR