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); Swelling (2091); Tingling (2171); Inadequate Pain Relief (2388); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (pseudoarthrosis, revision surgery).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) 2009, the patient underwent anterior lumbar interbody fusion surgery from vertebrae l4 to s1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, the patient suffered from increasing severe back pain, with pain radiating to her hips, buttocks and groin, and swelling in her legs.Severe pain and symptoms, and pseudoarthrosis, ultimately compelled patient to undergo a risky, painful and costly revision surgery on (b)(6) 2013.Despite revision surgery, patient continued to experience extreme pain in her lower back, with radiating pain down her legs, numbness and tingling in both legs, and swelling in her feet.She also experienced difficulty standing and walking for extended periods of time, and requires use of a motorized scooter when grocery shopping.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

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.

• 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: 5768510
• MDR Text Key: 48710970
• Report Number: 1030489-2016-01981
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110707AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2008
• 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): Required Intervention