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 Swelling (2091); Weakness (2145); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on, (b)(6) 2014: patient underwent following procedure: l5-s1 laminectomy and diskectomy (rt side).Posterior fusion l4-s1.Transverse lumbar interbody fusion l5-s1.Insertion of prosthetic device (12mm height).Posterior on-segmental instrumentation l5-s1 (pedicle screw system).Rhbmp ii mixed with local autograft for transverse lumbar interbody fusion and posterior fusion.Retractor system used for the above procedure for less invasive spine surgery.On (b)(6) 2014: patient presented with migraine, nausea, photophobia.On (b)(6) 2014: patient underwent aspiration and/or injection of joint, bursa, cyst, or periarticular structure.On (b)(6) 2015: patient underwent ct of the head without contrast.Impression: no acute intracranial pathology.Stable ct examination of the head.On (b)(6) 2015: patient presented with increased neck pain, pain behind lateral eyes, nausea and migraine.On (b)(6) 2015, (b)(6) 2014: patient underwent physical therapy.Patient presented with swelling of limb, neck pain, low back pain, chronic pain syndrome, migraine, hypertension, ganglion of joint.Patient presented with lower back, knees, neck pain.On (b)(6) 2015: patient underwent physical therapy.Assessment: patient presented with bilateral chondromalacia patella.Pt with surgical "hx" (rod in r femur, pubic symphysis and l5/s1 pedicle fixation).Pt reports decreased pain with tape application.Improved tolerance for exercise.Remains motivated.Weakness in hips (unable to keep knees inline with higher resistance during squats) but remains very motivated.On (b)(6) 2015, (b)(6) 2014, (b)(6) 2013, (b)(6) 2012: patient presented with lower back, knees, neck pain.On (b)(6) 2015: patient presented with chronic 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5509649
• MDR Text Key: 40639610
• Report Number: 1030489-2016-00719
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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
• Date Manufacturer Received: 02/22/2016
• 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 Weight: 77