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

Catalog Number KY_UNK_XSTOP

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

Patient Problems Bone Fracture(s) (1870); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Literature citation: atsufumi nagahama, misao nishikawa, seiya masamura, yuki ohata, toshiyuki kawashima, hiromichi ikuno"patient outcomes of spinal stabilization (x-stop insertion) for lumbar canal stenosis".Mean age: 74.5 years.Pt gender: 5 females, 30 male.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.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 total of 35 patients underwent spacer surgery for lumbar spinal canal stenosis.As postoperative complications, five patients had fracture or osteolysis at the spinous process where spacer was inserted,.

Manufacturer Narrative

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

• 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: 5777803
• MDR Text Key: 49020336
• Report Number: 1030489-2016-02015
• 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,Followup
• Report Date: 06/09/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KY_UNK_XSTOP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: 06/09/2016
• Supplement Dates FDA Received: 09/23/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR