MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNID PATIENT SPECIFIC IMPLANTS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	B33244599-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d3, d4, h4, h11 radiographic image review: the ap x-ray of lumbar sacral iliac construct was provided.One of the rods is fractured above the l5 screw, labelled as 'right' side.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.
Additional Manufacturer Narrative
Additional information: d1, d2, d4, g4.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.
Additional Manufacturer Narrative
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 healthcare provider (hcp) via a manufacturer representative regarding a patient having t11 to the iliac posterior spinal fusion.It was reported that postoperative x-rays taken for measurement protocols for a clinic visit on (b)(6) 2024 revealed a right rod fracture above the l5 screw, with both rods still implanted.The patient had initial surgery on (b)(6) 2024.It was unknown if solid fusion was achieved.No patient complications have been reported as a result of this event.

• Brand Name: UNID PATIENT SPECIFIC IMPLANTS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea road; memphis,tn 69140 ; FR 69140
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea road; memphis,tn 69140 ; FR 69140
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23120057
• Report Number: 1000432246-2025-00022
• Device Sequence Number: 9352794
• Product Code: KWP
• UDI-Device Identifier: 03613720289777
• UDI-Public: (01)03613720289777(17)240813(10)0228822951
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K220724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2025

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 Expiration Date: 08/13/2024
• Device Model Number: B33244599-01
• Device Catalogue Number: B33244599-01
• Device Lot Number: 0228822951
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/25/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/19/2025; 12/10/2025
• Date Device Manufactured: 05/04/2024
• 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
• Patient Sex: Male