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

Catalog Number	1-3206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/17/2013
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.
Event or Problem Description
The patient with lumbar spinal canal stenosis underwent implantation of interspinous process spacer.The patient was discharged on (b)(6) 2012.Aggravation of zcq score was observed.The patient¿s 12 month postoperative crf was finished, and on (b)(6) 2013, it was decided to continue postoperative the patient¿s observation.
Event or Problem Description
Additional information was reported from the patient¿s 12 months postoperative crf :"the baseline zurich claudication questionnaire(zcq) had not been evaluated.Deterioration in zcq at postoperative 12 months was not an adverse event.".
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6629048
• Report Number: 1030489-2017-01492
• Device Sequence Number: 1122602
• Product Code: NQO
• UDI-Device Identifier: 00643169132856
• UDI-Public: 00643169132856
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2017

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: 11/08/2012
• Device Catalogue Number: 1-3206
• Device Lot Number: 2244161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 06/26/2017; 06/26/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/25/2017; 10/04/2017
• 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
• Patient Age: 86 YR
• Patient Weight: 55