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

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

Patient Problems Ossification (1428); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of 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 patient underwent anterior and posterior lumbar fusion at l4-s1 in which rods, cages, screws and rhbmp-2/acs was implanted.It was alleged that patient developed foot drop on left leg immediately following surgery.Patient underwent radiology test where overgrowth of bone is alleged.Neurologist noted s1 nerve damage on testing.The patient had a lot of complications and suffered due to pain.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6688784
• MDR Text Key: 79119455
• Report Number: 1030489-2017-01673
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/07/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: No
• 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