MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA MEDICREA LEGACY TL; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number B33225512-07

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2020

Event Type  malfunction  

Event Description

Information received from user facility via manufacturer representative regarding an event happened during post-op of the reported product.It was reported that, the rod was broken.Based on the post-operative images the rod broke in the patient sometime after initial unid surgery.As of on (b)(6) 2022, the broken rods are still in the patient.The original unid surgery was a revoision case as in, there was already previous posterior and anterior hardware in the patient before the unid rods were implanted.The event was not reported by a healthcare professional, it was created by unid lab engineer because the broken rod was seen in the postop x-rays.Physician was aware of the broken unid rod, and the broken rod is still currently in the patient.Physician does not have any plans of a revision surgery to take the broken rod out because the patient has a fusion at that level.Physician did not reported any patient symptoms or complications as a result of this event.The exact event date was unknown, but by looking at the post-op dates the broken rod occurred between 1/7/20 and 6/2/20.No further complications reported.No further complications reported.

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.

• Brand Name: MEDICREA LEGACY TL
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 15202416
• MDR Text Key: 304977656
• Report Number: 1000432246-2022-00049
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 03613720268680
• UDI-Public: 03613720268680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33225512-07
• Device Catalogue Number: B33225512-07
• Device Lot Number: 19K0352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/10/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male