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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported in an abstract that total of 28 patients underwent an interspinous process decompression procedure using an interspinous spacer.All patients were asymptomatic while in a sitting position but developed symptoms in their legs when standing or walking during the pre-operative period.Treated levels included l4/5 [n=27], l3/4 [n=2].According to the abstract, there was one posterior implant displacement reported.No further information was reported.

Manufacturer Narrative

Literature citation : naohiro kawamura, junnichi kunoki, kazuhiro masuda, kengo fujii."posterior decompression and stabilization for lumber spinal stenosis".1406-04; s3-1-4.7/10/2014.(b)(4): unknown products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• Brand Name: THE X-STOP® INTERSPINOUS SPACER
• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3929979
• MDR Text Key: 4597554
• Report Number: 1030489-2014-03229
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040001
• 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: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 07/11/2014
• 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 Age: 00073 YR