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

Catalog Number 1-3208

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 07/16/2014

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Although it is unknown whether both the reported devices led to the event or not, we are filling this report for notification purposes.Mentioned device with quantity 2 were involved in the event.

Event Description

Pre-op diagnosis: lumbar spinal canal stenosis it was reported that on the patient underwent unspecified surgery and laminectomy at l3-l4 and l4-l5 using spacer due to lumbar spinal canal stenosis.Post-op, patient complained of strong back pain.On (b)(6) 2014 an image inspection was conducted which revealed that the interspinous expansion had not been maintained because of the abnormal positioning of the implants.Patient underwent revision surgery for removal of the implants.

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7014369
• MDR Text Key: 91493641
• Report Number: 1030489-2017-02286
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00643169132849
• UDI-Public: 00643169132849
• 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,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2017

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 Expiration Date: 03/07/2013
• Device Catalogue Number: 1-3208
• Device Lot Number: 2253691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2011
• 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; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 54