MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA PASS LP; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number B02316545Z

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

Patient Problems Fever (1858); Inflammation (1932); Sepsis (2067)

Event Date 10/13/2018

Event Type  Injury  

Manufacturer Narrative

Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.G2: country of event - france.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 Description

Information received from healthcare provider, clinical study via manufacturer representative regarding an event happened during post-op of the reported product.It was reported that, patient had postoperative sepsis.Post operative sepsis (fever and inflammatory scar) has occurred after surgery, the sepsis has been treated by surgery and anti-biotherapy.Investigator assessment states, causal relationship to study procedure.Sponsor assessment states, adverse event was causal relationship to reported device.There was no malfunction associated with reported product.Any diagnostic tests performed: yes.Did the ae result in the subject being hospitalized or a prolongation of an existing hospitalization: new hospitalization.Start date of the hospitalization: (b)(6) 2018, end date of hospitalization: (b)(6) 2018, patient outcome: recovered/resolved on (b)(6) 2018.

• Brand Name: PASS LP
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17478185
• MDR Text Key: 320586773
• Report Number: 1000432246-2023-00014
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 03613720185383
• UDI-Public: 03613720185383
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B02316545Z
• Device Catalogue Number: B02316545Z
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 88 KG