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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Although it is unknown if the device caused or contributed to the event or not, we are filing this report for notification purposes.(b)(6) hosp, (b)(6).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.

Event Description

It was reported that on (b)(6) 2009, the patient was pre-operatively diagnosed with recurrent lumbar stenosis and spondylolisthesis, l3-4 and l4-5, status post previous l2-3 fusion and underwent the following the procedures: transforaminal lumbar interbody fusion, left l3-4 and left l4-5, using 8mm peek transforaminal lumbar interbody fusion spacers packed with rhbmp2.Gill procedure, l2-3 and l3-4 and l4-5 with lateral mass fusion using matchsticks, allograft at l2 to l5.Removal of old pedicle screws and rods, l2-3.Placement of new pedicle screws and rods, l2, l3, l4 and l5, using 6.5 x 50mm cannulated screws, 100mm curved rods and two 40mm crosslinks.Reduction of spondylolisthesis, open, l3-4 and l4-5.Lateral recess decompression with foraminotomies, l3-4 and l4-5 bilaterally.As per op-notes,¿ the discs were then cleaned out with digger rongeurs until all endplates were removed.The deep portions of the discs were irrigated with antibiotic solution and packed with rhbmp2, autograft.An 8 mm peek spacer was packed with rhbmp2 and boomeranged across the midline at both levels.While this was occurring, distraction was carried upward reducing the spondylolisthesis and prior to this, gill procedures had been done to release the facets.¿ 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7141516
• MDR Text Key: 95585869
• Report Number: 1030489-2017-02546
• 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
• Report Date: 12/22/2017

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: 12/04/2017
• Initial Date FDA Received: 12/22/2017
• 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