MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON¿ MODULEX¿ SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	559200029
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient having spinal therapy.Prior to the index surgery, therapies attempted for the spine symptoms included oral medications, physical therapy, and steroid injections it was reported that during an index spinal surgery, there was an instrumentation failure related to poor bone quality and obesity.Diagnostic tests conducted included an x-ray, which showed evidence of screw pullout, and a computed tomography scan, which indicated minimal lucency around the tip of the right s1 screw, suggesting possible loosening.No obvious hardware fracture or additional perihardware lucency.The adverse event led to a new hospitalization starting on (b)(6) 2025, and an additional spinal surgery was performed on (b)(6) 2025, due to screw pullout attributed to poor bone quality and obesity.The outcome of the adverse event was reported as recovering/resolving.The investigator assessment were performed, and the adverse event was assessed as not related to the study procedure and study device.Sponsor assessments were performed that were different from investigator, and the adverse event was assessed as causal related to the study procedure - index surgery.But not related to the study device.Diagnostic test: x-ray diagnostic test result: evidence of screw pullout at right side of s1 diagnostic test date: on (b)(6) 2025 diagnostic test: computed tomography diagnostic test result: minimal lucency around tip of right s1 screw could indicate loosening.No obvious hardware fracture or additional peri hardware lucency.Additional information was received via manufacturer representative that investigator assessed as event not related to device but noted that screw pullout due to poor bone quality and obesity and underwent additional spinal surgery (revision l3-s1).Additional information was received via follow up mpxr that the instrumentation failure related to poor bone quality and obesity.Minimal lucency around tip of right s1 screw could indicate loosening.No obvious hardware fracture or additional peri hardware lucency.
Additional Manufacturer Narrative
B2: outcome attributed to adverse event is additional surgery due to instrument malfunction.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.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
D4: lot number 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
Additional information was received via follow up mpxr that the hospitalization end date updated to (b)(6) 2025 and site procedure relationship updated to possible related to the index procedure.

• Brand Name: CD HORIZON¿ MODULEX¿ SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; rd 909; barrio marianna km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; rd 909; barrio marianna km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22016094
• Report Number: 1030489-2025-01960
• Device Sequence Number: 8804828
• Product Code: NKB
• UDI-Device Identifier: 20763000972770
• UDI-Public: 20763000972770
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K221244
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 559200029
• Device Catalogue Number: 559200029
• Device Lot Number: UNKNOWN
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 08/15/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown
• Patient Weight: 107 KG