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

Catalog Number	1-3208
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2014
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7014369
• Report Number: 1030489-2017-02286
• Device Sequence Number: 19032582
• Product Code: NQO
• UDI-Device Identifier: 00643169132849
• UDI-Public: 00643169132849
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2013
• Device Catalogue Number: 1-3208
• Device Lot Number: 2253691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 54