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

Catalog Number 1-3210

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 05/14/2012

Event Type  malfunction  

Event Description

It was reported that a patient with concurrent prostate cancer underwent a surgery using an interspinous process spacer at l4/l5.Thirty-two days post-op during the one-month follow-up, imaging examination (i.E., x-ray) was performed, showing the spacer had migrated backward.No additional surgery or other treatment were performed.The event severity was non-serious.The event outcome was reported to be no health damage on (b)(6) 2012.The physician commented that the event could be partially attributable to the patient¿s somewhat small l5 spinous process.

Manufacturer Narrative

(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.

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea rd.; memphis TN 38118
• 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: 4778677
• MDR Text Key: 5803720
• Report Number: 1030489-2015-00991
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1-3210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2015
• 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 Age: 00083 YR
• Patient Weight: 61