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

Catalog Number	1-3212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is unknown if the device contributed to the reported event we are filing this mdr for notification purposes only.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with lumbar spinal canal stenosis underwent implantation of interspinous process spacer at l4-5.Post-op, the patient presented for a follow up visit with complaints of presence or absence of low back part and lower limbs pain.There was an aggravation of 'zcq' score.No product malfunction was reported.
Event or Problem Description
Additional information was reported from the patient¿s 3 years postoperative crf :buttock pain and left leg pain were confirmed to be improved (date of follow-up was unknown).

• 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: 6394180
• Report Number: 1030489-2017-00505
• Device Sequence Number: 1002533
• Product Code: NQO
• UDI-Device Identifier: 00613994598745
• UDI-Public: 00613994598745
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2012
• Device Catalogue Number: 1-3212
• Device Lot Number: 2228531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided; 03/27/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/06/2017; 09/30/2017
• 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