MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Literature citation: kunogi junichi, sakamoto ryuji, masuda kazuhiro, kawamura naohiro "complications and revision surgery of minimally invasive spinal surgery; complications and strategy of x-stop for lumbar spinal canal stenosis" 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.

Event Description

It was reported in abstract that total of 133 patients with lumbar spinal stenosis underwent surgery to implant interspinous process spacer from 2011 dec to 2014 mar.Out of those 133 patients, one patients had spinous process fracture.

• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• 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: 6201715
• MDR Text Key: 63176472
• Report Number: 1030489-2016-03498
• Device Sequence Number: 1
• Product Code: NQO
• 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
• Report Date: 11/29/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/23/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other