MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK X-STOP INTERSPINOUS SPACER SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number UNKNOWN

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Literature citation: yoshiyasu arai, kenichiro sakai, ichiro sakai, masaki tomori, masato yuasa, satoshi sumiya, koichi sato, atsushi ookawa; "indirect decompression of spondylolisthesis-comparison between olif and xstop-".Mean age: 65.1 years.(b)(4).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 an abstract that comparison study of 14 patients who underwent olif and 10 patients who underwent intra spinous spacer procedure (8 single-level fixations and 2 two-level fixations, mean age: 65.1 years old) was conducted.The following post-op complications were observed respectively: intra spinous spacer procedure : 1 intra-op spinous process fracture.

• Brand Name: X-STOP INTERSPINOUS SPACER SYSTEM
• 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: 5255889
• MDR Text Key: 32352888
• Report Number: 1030489-2015-03189
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/27/2015

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/30/2015
• 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
• Patient Age: 00065 YR