MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA UNKNOWN; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number UNKNOWN_MEDICREA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 10/23/2021

Event Type  Injury  

Manufacturer Narrative

The device was not 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.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having t4-l3 spinal th erapy for an adolescent idiopatic scoliosis.It was reported that the abscission of the anterior hook and cut off of the proximal part of the rods was performed on (b)(6) 2021 due to pain in the proximal part of the instrumentation; projection of the bilateral rods and a feeling of mobile material probably the suproloximar hook. there were no further complications reported regarding the event.

Manufacturer Narrative

H10: radiographic image review: the multiple ap/lateral images for pre-op and post-op of tl scoliosis correction are provided.Image quality is poor, difficult to estimate type of construct on provided images for complaint of abscission.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: UNKNOWN
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 16059369
• MDR Text Key: 306244484
• Report Number: 1000432246-2022-00064
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN_MEDICREA
• Device Catalogue Number: UNKNOWN_MEDICREA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• 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
• Patient Age: 18 YR
• Patient Sex: Female