MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ARTHROSCOPE

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

Patient Problems Numbness (2415); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: narihiro toshiki, masumi iwabuchi, osamu shirado"thoracic myelopathy resulting from balloon kyphoplasty for the treatment of t12 vertebral fracture.A case report" (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in an abstract that woman who had delayed union after th12 vertebral fracture underwent balloon kyphoplasty in a previous hospital.Five months post-op, the patient developed numbness in her lower limbs, inability for standing / walking.She consulted this hospital and was examined by simple x-p, ct and mri to find out she had th12 collapse, progression of kyphosis and spinal cord compression due to protrusion of posterior vertebral wall into spinal canal.She underwent anterior decompression and fusion and one year post-op, she regained muscle strength and is able to walk on her own.

Manufacturer Narrative

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

• Type of Device: ARTHROSCOPE
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5764923
• MDR Text Key: 48639882
• Report Number: 1030489-2016-01945
• Device Sequence Number: 1
• Product Code: HRX
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• 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?: Yes
• Date Manufacturer Received: 06/03/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR