MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	G5932105656
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding spinal product that is used in s pinal fusion therapy for th9/sai fixation for lumbar kyphosis.It was reported that the during the final tightening the set screw could not be broken off, the device was stripped.There were no further complications or symptoms reported.Additional information was received via manufacturer representative that it is unknown whether there was an allegation with mdt set screw and it was disposed off.
Additional Manufacturer Narrative
H3: product analysis of part (b)(4) , lot# 0949158w visual and optical inspection confirmed the threads of the domino appear to be stripped/damaged.The damage appears to be from misalignment and crossthreading.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CD HORIZON® SPINAL 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19246766
• Report Number: 1030489-2024-00396
• Device Sequence Number: 7332594
• Product Code: KWP
• UDI-Device Identifier: 00763000584344
• UDI-Public: 00763000584344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: G5932105656
• Device Catalogue Number: G5932105656
• Device Lot Number: 0949158W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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
• Patient Sex: Unknown