MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M

Model Number	6550002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event which occurred during a revision surgery due to lower back pain, due to the looseness of the l5 screw, there was concern about intervertebral instability at l4/5 after the initial l4/5 olif procedure.It was reported that after removing the left l4 screw, the reported product sv56 cnmas 7.5x50 was attached to the retaining screwdriver and inserted.The torque was applied during the insertion of the pps and the tip portion of the retaining screwdriver was broken and remains in the sv56 cnmas 7.5x50.The cut rod was finally tightened and the sv56 cnmas 7.5x50 was removed.Loosening was observed in the two screws on the left and right sides of l5.Relationship between "lower back pain" and "loosening of the l5 screw" is unknown.The physician believed that the l5 loosening occurred and a fine movement might remain in between the vertebrae on l4/5.The loosened l5 screw was removed during repeat surgery and replaced with medtronic product.Fragment of the screwdriver tip remained in the core of the screw.It became difficult to remove.In the end, it was removed. there was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis: part # 6550002, lot # nm17g007, visual and optical inspection confirmed the torx tip has been sheared off.Optical inspection confirmed a flat surface fracture with circular material displacement.This type of damage is consistent with torsional overload.H11: 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® SOLERA® VOYAGER¿ SPINAL SYSTEM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M
• 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: 21280949
• Report Number: 1030489-2025-00492
• Device Sequence Number: 12753021
• Product Code: HWE
• UDI-Device Identifier: 00643169754492
• UDI-Public: 00643169754492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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: 6550002
• Device Catalogue Number: 6550002
• Device Lot Number: NM17G007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2017
• 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 Sex: Male