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

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) 2011: the patient was pre-operatively diagnosed with: myofascial pain syndrome, lumbar.Lumbar pseudoarthroses.Lumbar spondylosis.Lumbar instability.Status post previous internal stabilization/ fusion from l3 through s1 ( (b)(6) 2010).Obesity with body mass index greater than 32.Non-insulin-dependent diabetes mellitus.Hypertension.Rheumatoid arthritis requiring immunosuppressive therapy.Vascular disease requiring antiplatelet therapy and underwent the following procedures: re-exploration of lumbar spine.Resection of subcutaneous scar.Examination of previous fusion at: l3-4, l4-5 and l5-s1 (visual, manual, fluoroscopic).Removal of previous stabilizing hardware.Repair of sacral screw holes with hydrocet.Internal stabilization from l1 through s1, bilateral, using autogenous bone plus autologous bone plus bone morphogenic protein.Preparation of bone graft.Intra-operative fluoroscopy.As per op-notes, ¿two large rhbmp-2 packages were rehydrated according to supplier¿s instructions and allowed to assimilate for more than 30 minutes.This was placed over the bone graft from l1 through s1 on both sides.¿ 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: 6850981
• MDR Text Key: 85270524
• Report Number: 1030489-2017-02008
• 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: 08/14/2017

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: 08/14/2017
• Initial Date FDA Received: 09/08/2017
• 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