MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., HU CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55840007545
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient with clinical id: (b)(6).On (b)(6) 2025, a ct (diagnostic) reported abnormal findings with haloing around the l2 and pelvic screws consistent with screw loosening, with pelvis instrumentation in place and early partial fusion noted.The patient has a history of lumbar surgery (laminectomies in 1999 and 2000 at l4/l5¿l5/s1).The primary diagnostic indication was stenosis with documented pre-operative instability, with four consecutive levels (l2¿s1) treated.Site assessment indicated a causal relationship to the interbody fusion device, posterior fixation device, plf grafting material, and the surgical construct/procedure.Sponsor assessment concluded the event is causally related to the posterior fixation device and not related to the procedure, plf grafting material, or the interbody device.No additional clinical symptoms or complications were provided in the report.
Additional Manufacturer Narrative
L2 and pelvic screws were loose in the same patient/event.The specific identifiers of the loose screws could not be confirmed.The following product ids and lot numbers were present at implant: [list all other 11].The failed screws¿ exact serial/lot/udi-pi remain unknown.Product id:, lot#:, udi:, 510(k) 55840007545, h5332527, 643169004344, k113174, 55840007545, 0217834w, 643169004344, k113174, 55840007545, h5326897, 643169004344, k113174, 55840007550, h5753508, 643169004351, k113174, (qty-2), 25630018580, ca16l048, 643169412620, k153442, 25630018580, ca21m059, 643169412620, k153442, 55840006545, h5648850, 613994971753, k113174, 55840006545, h5659108, 613994971753, k113174, 55840007545, h5233246, 643169004344, k113174, 55840007545, h13g0838, 643169004344, k113174.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
B5.Desc evt problem 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.
Event or Problem Description
2025 oct 18, update received: there were no symptoms related screw loosening- overall patient is better.2025 oct 29, update received: on (b)(6) 2025, diagnostic x-ray (xr-2) was abnormal, showing dextroscoliosis; spinal alignment and instrumentation were adequate from l2 to the pelvis, with instability noted at l1¿l2.
Additional Manufacturer Narrative
B5.Desc evt problem 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.
Event or Problem Description
2025 nov 13, update received: cec assessment: causal related to the posterior fixation and to the procedure and not related to the plf grafting and to the interbody device.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23321955
• Report Number: 2647346-2025-00151
• Device Sequence Number: 15939765
• Product Code: KWP
• UDI-Device Identifier: 00643169004344
• UDI-Public: (01)00643169004344(11)220228(10)H5746549
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/23/2026

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: 55840007545
• Device Catalogue Number: 55840007545
• Device Lot Number: H5746549
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/18/2025; 11/13/2025; 06/22/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/11/2025; 12/02/2025; 06/23/2026
• Date Device Manufactured: 02/28/2022
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American