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

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

Patient Problems Neuropathy (1983); Weakness (2145); Numbness (2415)

Event Type  Injury  

Event Description

It was reported in a journal article that a patient with a history of metastatic squamous cell carcinoma of the tongue underwent a percutaneous kyphoplasty for a painful t9 metastatic compression fracture.Immediately after the procedure, the patient developed saddle anesthesia and progressive bilateral lower extremity numbness and weakness.Computed tomography and magnetic resonance imaging revealed kyphoplasty cement within the t9 vertebral body with retropulsion of tumor mass into the ventral spinal canal.The patient underwent emergent posterolateral decompression with t9 vertebrectomy, anterior reconstruction t8-t10, and posterior instrumented spinal fusion.Histopathological examination confirmed the diagnosis of metastatic squamous cell carcinoma.Postoperatively, the patient regained full strength and sensation along with the ability to ambulate.

Manufacturer Narrative

Literature citation: sean m.Esmende, md; alan h.Daniels, md; mark a.Palumbo, md."spinal cord compression after percutaneous kyphoplasty for metastatic compression fracture".The spine journal 13 (2013) 831-832.(b)(4).

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4204372
• MDR Text Key: 20454221
• Report Number: 1030489-2014-04143
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• 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?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PKP
• Patient Outcome(s): Required Intervention
• Patient Age: 00065 YR