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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that a patient underwent a spinal surgery using an interspinous spacer at l4-l5 on an unspecified date.Sometime post-operatively, the patient fell and made a follow up appointment.Imaging results revealed that the interspinous spacer may have "migrated" posteriorly.No accompanying symptoms were noted.According to the report, no revision surgery is being considered at this time.

Manufacturer Narrative

Additional information: imaging interpretation: ap and lateral views are provided of very poor quality after x-stop surgery.The films were apparently taken after a fall.No change in symptoms were reported.Without x-rays taken prior to the fall no change in position of the device can be verified.It appears however, that the l5 spinous process may have been fractured as the device is sitting in the position of the l5 spinous process, still near the dorsal extent of the facet joint.The ap also shows rotation of the device that cannot be linked to the fall or fracture without previous films.

Manufacturer Narrative

(b)(4).

• Brand Name: X-STOP®PEEK 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: 4078888
• MDR Text Key: 4852300
• Report Number: 1030489-2014-03667
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• 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
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 00089 YR