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

Catalog Number 1-3206

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/17/2013

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.

Event 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 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.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6629048
• MDR Text Key: 77220628
• Report Number: 1030489-2017-01492
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00643169132856
• UDI-Public: 00643169132856
• 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,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2012
• Device Catalogue Number: 1-3206
• Device Lot Number: 2244161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 06/26/2017; 06/26/2017
• Supplement Dates FDA Received: 07/25/2017; 10/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2010
• 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
• Patient Age: 86 YR
• Patient Weight: 55