MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® GROWTH ROD CONVERSION SET; GROWING ROD SYSTEM

Model Number	7340000GR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter details are unknown, g2: country of origin - japan 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that they removed fragments of the set screw after final tightening.Fragments of the product fell to the pleura level, raising suspicions of complications involving the lung.There was no patient symptom reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that the type of procedure/therapy involved during the event was glow ingrod method for childhood scoliosis.Reoperation due to one-sided rod breakage.Rod implanting date: (b)(6) 2024.The damaged rod was removed and a new rod was installed.The actual product has been discarded and could not be returned.A threaded piece of the set screw fell out into the body.

• Brand Name: CD HORIZON® GROWTH ROD CONVERSION SET
• Common Device Name: GROWING ROD SYSTEM
• 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: 21718519
• Report Number: 1030489-2025-01579
• Device Sequence Number: 9492551
• Product Code: PGM
• UDI-Device Identifier: 20643169549771
• UDI-Public: 20643169549771
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: 7340000GR
• Device Catalogue Number: 7340000GR
• Device Lot Number: UNKNOWN
• 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: 03/08/2025
• Initial Report FDA Received Date: 03/28/2025
• 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