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 07/22/2014

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

Levels implanted: l4-l5 followings were reported via a clinical study: date hospitalized, surgery date, date discharged: (b)(6) 2013, comments in case for the patient is still hospitalized, or discharge of the patient was delayed: there is no hospitalization/discharge from the hospital due to a day surgery.Name of adverse events/malfunction: dislocation of the implant.Cage 10mm, causality relationship between the event and could not be ruled out.Severity: serious.Additional surgery: removal of implant and laminectomy.Other additional treatment: none.Outcome date: (b)(6) 2015.Outcome: remission.Details of the adverse event or nonconformity: preoperative examination was performed on (b)(6) 2014.On (b)(6) 2014, implant was removed, and laminectomy was performed.Rehabilitation was performed at other hospital after discharge.Last visit to our hospital was on (b)(6) 2015.Comments for the adverse event or nonconformity: preoperative examination was performed on (b)(6) 2014.On (b)(6) 2014, implant was removed, and laminectomy was performed.Rehabilitation was performed at other hospital after discharge.Last visit to our hospital was on (b)(6) 2015.Type of end/withdrawal: withdrawal.Date determined of end/withdrawal (b)(6) 2015.Reason for withdrawal: surgical treatment associated with the removal of this product was necessary, and it became difficult to continue to investigate the safety and efficacy of this product.Efficacy evaluation: the treatment was not effective for the patient.

• 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: 7581770
• MDR Text Key: 110457662
• Report Number: 1030489-2018-00822
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00643169132832
• UDI-Public: 00643169132832
• 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: 06/08/2018

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: 12/21/2014
• Device Catalogue Number: 1-3210
• Device Lot Number: RM12K009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2012
• 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: 71 YR