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

Catalog Number	1-3210
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/22/2014
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 7581770
• Report Number: 1030489-2018-00822
• Device Sequence Number: 2062808
• Product Code: NQO
• UDI-Device Identifier: 00643169132832
• UDI-Public: 00643169132832
• 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: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2014
• Device Catalogue Number: 1-3210
• Device Lot Number: RM12K009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/08/2018
• 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; Required Intervention
• Patient Age: 71 YR