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

Model Number	G3603512
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative regarding a screw used in posterior cervical fusion therapy for cervical dislocation fracture.It was reported that during the procedure, an attempt was made to install the screw to the screwdriver, but the screw head was fixated and could not be moved, so it could not be installed.It was determined to be a defective product, so a new product was opened and it was installed without any problems.The operation was completed successfully.The device did not come in contact with the patient.No patient symptoms were reported.It was reported that when the device was taken out of the box and attached to the screwdriver, the issue was noticed for the first time.It was the first use of the product.No further complications were reported/anticipated.
Additional Manufacturer Narrative
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.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: 21442479
• Report Number: 1030489-2025-00911
• Device Sequence Number: 4528278
• Product Code: KWP
• UDI-Device Identifier: 00643169542235
• UDI-Public: 00643169542235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 02/24/2025

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: G3603512
• Device Catalogue Number: G3603512
• Device Lot Number: H5740857
• 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: 10/13/2022
• Initial Report FDA Received Date: 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2022
• 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