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

Model Number	G559300156
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis:product id# g559300156; lot# h5826560 visual and optical inspection confirmed the gripper tabs of the screw have been bent/deformed due to bend stress overload.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 spinal therapy for t12 vertebral fracture.It was reported that the m5 domino was tried to be placed between the l1/2 screws, but because of reoperation, the bone had formed and the domino could not be placed properly.While trying to remove the fully formed bone with tools such as a chisel or sharp spoon and place the m5 domino again, the direction of the domino shifted while gripping it with the holder.At that time, the holder gripping portion of the domino was deformed.A new m5 domino was used, and the domino was successfully placed.The procedure performed was t12 pso, t7-l2 posterior fixation, rod connection.There was no patient symptom reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that there was damage at the grip of the domino connector.All damaged pieces have been recovered from the surgical field.

• Brand Name: CD HORIZON MODULEX SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19257475
• Report Number: 1030489-2024-00412
• Device Sequence Number: 2607777
• Product Code: NKB
• UDI-Device Identifier: 00763000465599
• UDI-Public: 00763000465599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/07/2024

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: G559300156
• Device Catalogue Number: G559300156
• Device Lot Number: H5826560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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