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

Model Number	G3603528
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient undergoing posterior cervical fusion at levels c1-3 for c1, c2 fracture.It was reported that the 28mm right c1 screw was shorter and was not touching the tip of the screw in the fracture line when inserting, so it was changed to 30 mm.There was a delay of less than 60 minutes.There was no patient symptoms or complications as a result of this event.No further complications were reported/anticipated.
Additional Manufacturer Narrative
H3: product analysis#: (b)(4): part#: g3603528, lot#: h5775137 - visual and optical inspection did not reveal any damage to the screw.Details in the event confirm wrong screw was chosen.No fault found.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: 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: 21650419
• Report Number: 1030489-2025-01470
• Device Sequence Number: 9276439
• Product Code: KWP
• UDI-Device Identifier: 00643169542310
• UDI-Public: 00643169542310
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: G3603528
• Device Catalogue Number: G3603528
• Device Lot Number: H5775137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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 Sex: Unknown