MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ARTHROSCOPE

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

Patient Problems Pain (1994); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Literature citation: yasunobu ito, shinichi numazawa, yoshitaka hirano, yoshio, mizumoto, atsushi sakai, tomoko otomo, sadayoshi watanabe, kazuo watanabe "surgical treatment on pseudarthrosis and related disorders with spinal compression fracture" mean age: 71.2 years.Pt gender: female: 4, male :1.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.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 that total of 70 patients with mean follow-up period of 6.8 months (1-17months) underwent balloon kyphoplasty from 2011 july to 2013 feb.Approx 55 patients underwent only balloon kyphoplasty and 15 patients had additional procedure for coexisting diseases after balloon kyphoplasty (lumbar spinal canal stenosis:8 , pseudarthrosis and related symptoms: lumbar spondylolisthesis: clinical symptoms and outcomes of the five patients with pseudarthrosis and related symptoms were investigated.These five patients had not only back pain, but also had problem in sitting, standing and walking with numbness in lower limbs and vesicorectal disorder.Out of five, one underwent single level balloon kyhphoplasty and the rest underwent two level balloon kyhphoplasty.After balloon kyhphoplasty, thoracolumbar pedicle screw fixation with posterior decompression <(>&<)> minimal invasive surgery was performed on those five patients (on three of them, cortical bone trajectory was performed).Postoperatively, back pain and functional disorders were improved.

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 38134
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38134
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6412557
• MDR Text Key: 70173999
• Report Number: 1030489-2017-00563
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• 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: 02/17/2017
• 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; Required Intervention
• Patient Age: 71 YR