MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CLYDESDALE PTC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 4986850

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Type  Injury  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with an indication of degenerative spondylolisthesis.It was reported that a patient who underwent l3-5 olif was discharged from the hospital, and two months later, an outpatient examination was performed because of pain at the surgical site.It was said that infection was suspected near the surgical site.There was postoperative infection (b)(6).According to the healthcare professional's opinion, disability was the patient symptoms or complications result of this event.Cleaning of infected area was additional treatment performed as result of this event.Patient condition improved.The reported event was not revision surgery.No delay in overall procedure time.Prolongation of existing hospitalization or in-patient hospitalization necessity was unknown.Product used correctly according to the directions given in the ifu/labeling.There was no implant breakage and device implanted and remains in service.No further complications were reported.

Event Description

Additional information received on 07-jan-2021.It was reported that there was no device related malfunction reported and on 2020/11/2, the consumer heard the voice of the possibility of event occurrence from the patient at the outpatient department.No further complications were reported.

Manufacturer Narrative

B5: new event information added.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: CLYDESDALE PTC
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• MDR Report Key: 10894710
• MDR Text Key: 217957028
• Report Number: 2647346-2020-00042
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K133205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4986850
• Device Catalogue Number: 4986850
• Device Lot Number: H5476856
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention