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

Model Number	B02316545Z
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: b02316545z, serial/lot #: unknown, udi#(b)(4) product id: b02316545z, serial/lot #: unknown, udi#(b)(4) product id: b02316545z, serial/lot #: unknown, udi#(b)(4).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
Information was 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 adjacent level stenosis at l3-l4 region.As a result, subject was hospitalized and concomitant medication - corticosteroids were administered.The adverse event was treated by performing additional decompression and osteosynthesis at l3-l4.There was no allegation/malfunction associated with reported pass degen screws.The levels implanted were l4-l5.Investigator assessment states, the ae was causally related to study procedure and not related to study device and unknown to instruments. sponsor assessment states, the ae was not related to study procedure and instruments.Possibly related to study device.Start date of the hospitalization: (b)(6) 2023 end date of the hospitalization: 07/dec/2023 date of additional surgery in the spine: (b)(6) 2023 proximal instrumented vertebra: l3 distal instrumented vertebra: l5 date ae first determined to be an sae: (b)(6) 2023.

• Brand Name: PASS LP
• Common Device Name: 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: 18515841
• Report Number: 1000432246-2024-00001
• Device Sequence Number: 12445424
• Product Code: NKB
• UDI-Device Identifier: 03613720185383
• UDI-Public: 03613720185383
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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 Model Number: B02316545Z
• Device Catalogue Number: B02316545Z
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG