MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	6900240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - 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.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.
Event or Problem Description
Information was received from regulatory body via a manufacturer representative regarding a patient having spinal therapy.It was re ported that the patient was admitted to the hospital due to cervical spondylotic myelopathy.On (b)(6) 2024, he underwent posterior cervical incision, decompression, bone grafting, fusion and internal fixation under general anesthesia.Rod and pedicle screws were used during the operation.During the hospital stay, the wound was normal and the patient was discharged without removing the stitches.On (b)(6) 2024, the patient was hospitalized again due to postoperative infection of the cervical spine.Debridement was performed and the patient was discharged after recovery.He did not follow the doctor's instructions to change the medicine regularly at the medical institution, but changed the medicine at home on his own, and did not have a strong sense of sterility.The patient was admitted to the hospital for the second time and underwent debridement, perfusion and drainage for postoperative infection of the cervical spine. there were no patient symptoms reported.There were no further complications reported regarding the event.Patient did not monitor his blood sugar after discharge.
Event or Problem Description
Information was received from regulatory body, healthcare professional via a manufacturer representative regarding a patient having spinal therapy.It was reported that the patient was admitted to the hospital due to cervical spondylotic myelopathy.On (b)(6) 2024, he underwent posterior cervical incision, decompression, bone grafting, fusion and internal fixation under general anesthesia.Rod and pedicle screws were used during the operation.During the hospital stay, the wound was normal and the patient was discharged without removing the stitches.On (b)(6) 2024, the patient was hospitalized again due to postoperative infection of the cervical spine.Debridement was performed and the patient was discharged after recovery.He did not follow the doctor's instructions to change the medicine regularly at the medical institution, but changed the medicine at home on his own, and did not have a strong sense of sterility.The patient was admitted to the hospital for the second time and underwent debridement, perfusion and drainage for postoperative infection of the cervical spine.There were no patient symptoms reported.There were no further complications reported regarding the event.Patient did not monitor his blood sugar after discharge.
Additional 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: VERTEX RECONSTRUCTION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 19740146
• Report Number: 1030489-2024-00826
• Device Sequence Number: 19716479
• Product Code: KWP
• UDI-Device Identifier: 00681490885843
• UDI-Public: 00681490885843
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K003780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6900240
• Device Catalogue Number: 6900240
• Device Lot Number: 0953528W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/24/2024
• Date Device Manufactured: 04/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown