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

Model Number	1-3212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	09/10/2020
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
It was reported during use, stenosis was developed in the patient.So, revision surgery was performed to remove x-stop instrument.The x-stop instrument was removed and laminectomy was performed.There was no delay in overall procedure time.Patient was not hospitalized for prolong.Patient issue is resolved.Levels implanted in initial surgery- l4/5.Received updated information that patient recovered after the revision surgery.Reported there is no malfunction of the product.Patient outcome: no health damage in the patient was reported.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported during use, stenosis was developed in the patient.So, revision surgery was performed to remove x-stop instrument.The x-stop instrument was removed, and laminectomy was performed.There was no delay in overall procedure time.Patient was not hospitalized for prolong.Patient issue is resolved.Levels implanted in initial surgery- l4/5.Received updated information that patient recovered after the revision surgery.Reported there is no malfunction of the product.Patient outcome: no health damage in the patient was reported.On 2020-dec-17, received additional information that it is unknown whether the stenosis occurred due to the reported product.There was no product failure.Stenosis occurred at the implant site l4/l5.

• 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: 10606501
• Report Number: 1030489-2020-01359
• Device Sequence Number: 2682597
• Product Code: NQO
• UDI-Device Identifier: 00643169132825
• UDI-Public: 00643169132825
• 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: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 12/18/2014
• Device Model Number: 1-3212
• Device Catalogue Number: 1-3212
• Device Lot Number: RM12J019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 12/18/2020
• 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: Required Intervention
• Patient Age: 78 YR