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

(b)(6).(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.

Event Description

It was reported that on (b)(6) 2007 the patient complained of back pain, underwent a ct and presented with the following preoperative diagnoses: 1.Pseudoarthrosis at l3-4.2.Medially displaced screw at l4.The patient underwent the following procedures: 1.Removal of hardware at l3-4.2.Explore the fusion, found a pseudoarthrosis at l3-4.3.Re-fused at l3-4.4.Re-instrument at l3-4 with 5.5 titanium with x10 crosslinks, re-cannulating the pedicle at l3 on the right.5.Right iliac crest graft supplemented with a large rhbmp-2/acs kit and local bone graft.Per op notes: a midline incision was made through the original incision.The locking nuts were removed, followed by rods, couplers and then screws.All the screws and necks were removed.Next dissection was carried out laterally to the transverse processes of l3-l4 were identified and they were completely decorticated.This was followed by replacing all pedicle screws at l3 and l4 on the left and l4 on the right, 6.5 x 40 mm.It had a snug fit.The pedicle at l3 was probed because the old pedicle insertion site was probed; it was medially displaced into the canal.This was probed and then using an eeg monitor, tapped and then 5.5 x 40 mm screw was placed.Two rods were placed followed by four plugs.Decompression was done and bone graft was then tubularized in a bmp sponge.This along with copious bone graft was placed from l3 to l4 across the transverse processes out into the lateral gutters.

• 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: 5333142
• MDR Text Key: 34643856
• Report Number: 1030489-2015-03602
• 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: 11/30/2015

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: 11/30/2015
• Initial Date FDA Received: 12/29/2015
• 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