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

Catalog Number 7510200

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Numbness (2415); Ambulation Difficulties (2544)

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2007: the patient was pre-operatively diagnosed with left-sided l3-l4 far lateral and left-sided l4-l5 posterolateral disc herniations with l3, l4, and l5 left-sided radiculopathy, spinal instability and underwent the following procedures: left-sided l3, l4, and l5 lumbar laminectomies with complete facetectomies.Spinal instrumentation (pedicle screws at l3,l4, l5, and s1 levels.) arthrodesis, transforaminal lumbar interbody technique in the intervertebral spaces of l3-l4, l4-l5, and l5-s1.Application of biomechanical intervertebral devices at l3-l4, l4-l5, and l5-s1 (peek cages).Arthrodesis posterior lateral technique from l3 to s1.Intraoperative fluoroscopy.Pre-operatively, mri showed a significant l4-l5 posterior lateral disc herniation on the left side with compression of l4 and l5 nerve roots.The patient also had previous l5 left laminotomy for an acute herniated disc supposedly at l5-s1 in accordance with the patient, but, no records could be obtained.As per op-notes,¿ upon placement of the screws we performed transforaminal lumbar interbody fusion at l3-l4, l4-l5, and l5-s1 levels on the left side.The nerve roots were dissected and protected using love retractor of these disks were opened using 11-blade scalpel and complete discectomies were performed using transforaminal lumbar interbody fusion instruments.Good end-plate preparation was achieved using curettes and we placed 12 x 26 mm peek cage into the interspace of l3-l4, peek cage into the interspace l4-l5 and another peek 12 x 26 mm cage into the interspace l5-s1 interspace.Prior to placement of the cages we packed the interspaces with patient's own bone obtained from the lamina and mixed with bmp sponges.We also inserted bmp sponge with a piece of bone within each cage.Upon placement of the cages again fluoroscopy was performed.We ensured good position of the cages, 90 mm rods were placed into the tulips of the pedicle screws, compression was applied sequentially and bilaterally and another x-ray was performed to confirm good lordosis and good lock of the cages in the position.¿ the patient tolerated the procedure well without any intraoperative complications.Post-op, patient reported "progressively increasing low back pain and radicular symptoms in his lower extremities.Patient continues to experience chronic and extreme pain and muscle spasms in his lower back, radiating pain down his right leg, numbness in his left leg, and numbness in both feet.Patient was unable to walk extended distances, and suffers from bowel and sexual dysfunction".

• 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: 6982858
• MDR Text Key: 90395104
• Report Number: 1030489-2017-02270
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• 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