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 Problem Unspecified Infection (1930)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Information was received from clinical study, healthcare provider via manufacturer representative regarding an event happened during post-op of the reported product.It was reported that, patient exit the study due to spondylodiscitis.Patient developed secondary infection linked to the material with cutaneous start with spondylodiscitis.Patient was hospitalized from 12/jul/2020 to 12/aug/2020 and treated with antibiotics.Arthrodesis was performed on 30/jul/2020.Site (investigator) assessment states, adverse event was not related either to the procedure and to the device.Sponsor assessment states, causal related to the device but, not related to the procedure.Ae term updated: spondylodiscitis.Ae start date: 01/jul/2020 were any diagnostic tests performed: yes.Patient recovered on 09/sep/2021 no further complications reported regarding the event.

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.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.

• 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: 18245518
• MDR Text Key: 329467129
• Report Number: 1000432246-2023-00021
• 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: Physician
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 11/08/2023
• 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: 86 KG