MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CENTERPIECE PLATE FIXATION SYSTEM; ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Model Number	G8532067
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: country of origin is portugal.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 laminoplasty.It was reported that the head of a bone screw broke during introduction, resulting in the screw body remaining in the patient as a retained implant fragment.It was confirmed that the product was utilized according to the directions for use.No treatment or additional surgery was performed as a result of this event.There were no patient complications or symptoms have been reported as a result of this event.Additional information was received from manufacturer representative that there is no revision surgery scheduled or planned for the removal of broken fragments from patient.This event has been occurred due to potential manufacturing issue of the device.
Additional Manufacturer Narrative
H3: product analysis of part# g8532067, lot# h6074386 visual and optical inspection confirmed the screw has broken.The damage to the screw is consistent with 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.

• Brand Name: CENTERPIECE PLATE FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23905444
• Report Number: 2647346-2025-00275
• Device Sequence Number: 9038904
• Product Code: NQW
• UDI-Device Identifier: 00763000553470
• UDI-Public: (01)00763000553470(17)330804(10)H6074386
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K212428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: G8532067
• Device Catalogue Number: G8532067
• Device Lot Number: H6074386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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