MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; CEMENT, BONE, VERTEBROPLASTY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Literature citation "nodoka manabe, naofumi toda, ino masatake, tanouchi tetsu, fueki keisuke, kanako ito, takachika shimizu", "recompression and burst fracture of vertebral body after balloon kyphoplasty for osteoporotic vertebral compression fracture: a case report" (b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported via abstract that patient sustained fracture of l3 vertebral body after falling down which was treated conservatively.However, since dysraphism and pseudoarthrosis were observed, he underwent balloon kyphoplasty(bkp).Patient exhibited cauda equina syndrome consisting mainly of pain in both lower extremities one week after balloon kyphoplasty and underwent posterior decompression (laminectomy in l2,3 and 4) three weeks after balloon kyphoplasty.As a result, lower extremity pain improved.However, one month post-op, lateral radiograph and mri of the same vertebral body shows a severe burst fracture with cement leakage.Vertebral wall displaced into the spinal canal and bone cement leaked into dorsal portion of spinal canal.Liquorrhea, bladder and bowel dysfunction, incomplete paralysis in both extremities, gait disorder were observed additionally.Considering that he had osteoporotic vertebral fracture in multi levels and obvious collapse in anterior supporting elements, it was determined that posterior decompression fusion and anterior spinal fusion was necessary, and posterior fusion in t9-s2ai (s2 alar iliac) and anterior spinal fusion in l2-l4 were performed.Postoperatively, bladder and bowel dysfunction improved and he could walk with a cane.Joa score improved from 3 to 20 on 29 point scale.

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6739377
• MDR Text Key: 80864685
• Report Number: 1030489-2017-01817
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/25/2017
• 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): Required Intervention
• Patient Age: 73 YR