MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY¿ OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	G3603524
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Loss of consciousness (2418)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: outcome attributed to adverse event is loss of consciousness.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.E1: first name and last name of initial reporter is unknown.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.
Event or Problem Description
Information was received from a healthcare provider regarding a patient having spinal therapy for cervical fracture.It was reported that during a c2-c7 spinal fixation procedure, a potential misalignment of the navigation system (o-arm) resulted in the left pedicle screw at c4 being misplaced by 5 mm or more, posing a risk of vertebral artery (va) damage.Due to the high risk of hemorrhaging if repositioned, the surgical team decided to leave the screw in place and proceeded with wound closure.Post-operatively, the patient did not regain consciousness and was transferred to the ward.There were no further complications reported regarding the event.
Event or Problem Description
Additional information was received from the manufacturer representative indicating that bleeding was observed during the procedure, suggesting that the vertebral artery may have been damaged.However, there were no significant effects on the patient, and it appears there are no ongoing issues with the patient.And it was believed that the misalignment of the left c4 screw was caused by only pushing the left c4.Subsequently, o-arm/navigation has been used in cases without any problems.The surgeon had pushed the left c4 screw unexpectedly.The reported o-arm/navigation product in the event was not reported with any allegation.
Additional Manufacturer Narrative
B5: event problem description is updated.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: INFINITY¿ OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22381682
• Report Number: 1030489-2025-02375
• Device Sequence Number: 15848558
• Product Code: KWP
• UDI-Device Identifier: 00643169542297
• UDI-Public: (01)00643169542297(17)320617(10)H5964739
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G3603524
• Device Catalogue Number: G3603524
• Device Lot Number: H5964739
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown