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

Catalog Number 1-3210

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 09/20/2014

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-op diagnosis: lumbar spinal canal stenosis levels implanted: l4-l5 following was reported that on (b)(6) 2014 via a post market studay: (b)(6) 2012(day surgery), whether there were adverse events / malfunction during operation: none, adverse event 1: date of onset: (b)(6) 2014 adverse event / malfunction name: postoperative pain recurred, causal relationship with product: could not be denied, seriousness: serious, reoperation: yes (implant removal and laminectomy), other additional treatment: none outcome date: (b)(6) 2014, outcome: recovery, detailed information of adverse events / malfunction: (b)(6) 2014, right lower limb pain occurred suddenly.On (b)(6) 2014, it was confirmed that the position of the implant was abnormal by mri examination, and on (b)(6) 2014, implant removal and laminectomy were performed.Adverse event 2:date of onset: (b)(6) 2014 adverse event / malfunction name: implant was indwelt in an abnormal position, causal relationship with product: could not be denied, seriousness: serious, reoperation: yes (implant removal and laminectomy), other additional treatment: none outcome date: (b)(6) 2014, outcome: recovery, detailed information of adverse events / malfunction: (b)(6) 2014, right lower limb pain occurred suddenly.On (b)(6) 2014, it was confirmed that the position of the implant was anomaly by mri examination, and on (b)(6) 2014, implant removal and laminectomy were performed.Whether it was effective: ineffective, category of continuation / cancellation: cancellation, reason for discontinuation: surgical procedure associated with removing the product was required, and it became difficult to continue to investigate the safety and effectiveness of this product.Determination date of continuation /cancellation: (b)(6) 2014.

• 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: 7471725
• MDR Text Key: 106834546
• Report Number: 1030489-2018-00622
• Device Sequence Number: 1
• Product Code: NQO
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2018

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: 02/07/2013
• Device Catalogue Number: 1-3210
• Device Lot Number: 2245341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2011
• 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: 78 YR