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	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diagnosis for growing rod extension technique.Procedure or therapy performed was extension surgery for the growing rod.It was reported that the set screw broke before the break-off.During growing rod extension, the distractor came off and interfered with the set screw.It is believed that the breakage was caused by this impact.There was no patient symptoms or complications as a result of this event.This surgery is a repeat surgery.Device has been explanted-partially.Product was implanted and explanted on the same day, (b)(6) 2023.There were no fragments left inside the patient body, so no plan for additional surgery.
Additional Manufacturer Narrative
H3: product analysis of part # 734000gr: lot # 0883463w visual and optical inspection confirmed the break off portion of the screw has been broken.The female torx does have some deformation in the corners indicating the screw has been used.The driver may have not been seated properly when turning causing the break off portion to break.This regulatory report is being submitted due to retrospective review through capa 624392.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: 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: 21067994
• Report Number: 1030489-2025-00069
• Device Sequence Number: 18235701
• 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: 2023
• Device Explanted Year: 2023
• 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): 01/03/2025

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: 0883463W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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 Age: 9 YR
• Patient Sex: Unknown