MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA LIGAPASS; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number B08110005

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: b08110005, serial/lot #: 22a0231, ubd: 28-may-2027, udi#: (b)(4) ; product id: b08110005, serial/lot #: 22c0288, ubd: 04-jun-2027, udi#: (b)(4) ; product id: b08110005, serial/lot #: 22c0288, ubd: 04-jun-2027, udi#: (b)(4) ; product id: b08110005, serial/lot #: 22c0288, ubd: 04-jun-2027, udi#: (b)(4) ; product id: b08110005, serial/lot #: 22c0288, ubd: 04-jun-2027, udi#: (b)(4) ; product id: b08110005, serial/lot #: 22a0231, ubd: 28-may-2027, udi#: (b)(4) ; product id: b08110005, serial/lot #: 22a0231, ubd: 28-may-2027, 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 Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event happened during post-op of the reported product.Medical history of patient includes bad bone quality, heavy kyphosis.It was reported that, liga pass bands were broken.Four levels were implanted during initial surgery.Patient experienced pain as a result and revision surgery was performed to explant the broken band. there was no fragment of broken band left inside patient body.No further complications reported.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LIGAPASS
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• 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: 18280942
• MDR Text Key: 329889969
• Report Number: 1000432246-2023-00023
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K173506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B08110005
• Device Catalogue Number: B08110005
• Device Lot Number: 22C0288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Date Device Manufactured: 03/08/2022
• 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
• Treatment: "SEE H10"
• Patient Outcome(s): Required Intervention
• Patient Sex: Female