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

Catalog Number 7510400

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (revision surgery, persisting back pain).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) 2006 the patient underwent spine fusion surgery on the lumbar region of her spine from vertebrae l5 to s1 using rhbmp-2 from a posterior and posterolateral approach.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the lateral gutters).Patient continued to experience chronic lower back and sciatic pain, pain radiating down into her right leg and foot, numbness and tingling in her left leg and foot, spasms throughout the right side of her body, and pain radiating up her spine and into her neck and shoulders.Patient experienced difficulty in sitting, standing and walking for extended periods, difficulty sleeping due to pain, and limited mobility.She required use of a cane daily, and occasional use of a walker, to assist in ambulation.These serious injuries prevented patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively, and she otherwise suffered serious and permanent injuries.

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 the patient was pre-operatively diagnosed with radiculopathy status post transforaminal lumbar interbody fusion-tlif and underwent the following procedures: exploration of fusion, l5-s1.Removal of interbody cage, l5-s1.Redo fusion, l5-s1, using bmp.As per op-notes,¿ she still had some interbody fusion intact so we didn't feel it prudent to place another cage.We placed further bmp into the cage in the posterolateral gutter to augment her fusion.The wound was thoroughly and copiously irrigated prior to placement of bmp and then the pedicle screws retightened.¿ 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6295704
• MDR Text Key: 66316507
• Report Number: 1030489-2017-00190
• 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: 03/16/2018

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: 05/01/2009
• Device Catalogue Number: 7510400
• Device Lot Number: M115007AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: 01/09/2017; 03/12/2018
• Supplement Dates FDA Received: 09/28/2017; 03/16/2018
• 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