MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	RBT033101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having t4-pelvis psf for an indication of scoliosis.It was reported that the drivers were broken and the tab on shaft is broken, no longer retains set screws and the flex arm will not tighten.The drivers came in contact with the patient but the flex arm was not being used on the patient while the malfunction was noticed. there were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3.Device evaluation summary: product analysis #(b)(4).Lot# id19f049 visual and optical examination identified it appears that the driver's tip has been broken off.The metal deformation gives indication that the failure was the result of torsional overload.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 SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21442401
• Report Number: 1030489-2025-00891
• Device Sequence Number: 17275105
• Product Code: OLO
• UDI-Device Identifier: 00763000011307
• UDI-Public: 00763000011307
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2025

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: RBT033101
• Device Catalogue Number: RBT033101
• Device Lot Number: ID19F049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male