MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CENTERPIECE¿ PLATE FIXATION SYSTEM; ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Model Number	8532065
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of part# 8532065, lot#: unknown three screws returned all three screws have been broken at the shaft a microscopic review of the fracture face indicates that the fracture is the result of torsional overload combined with at bending moment.The failure is the result of material overload.*the originally pli 10 had a qty.Of 3 as part of capa 624392 each qty is given its on pli* h11: this regulatory report is being submitted due to retrospective review through capa 624392.Radiographic image review states that - intra-op imaging for cervical laminoplasty.2 images provided.System appears intact at c3-4, but visualization of the anatomy and implants below these levels is difficult because of patient anatomy.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 a healthcare professional via manufacturer representative regarding bone screws used in laminoplasty c3-7 therapy for cervical stenosis.It was reported that the threaded portion of the screw broke off in the corresponding levels and anatomy - one at c6 lamina and two at c7 lateral mass.Fragment of the implant was remaining in the patient.No additional surgery was performed.No patient symptoms were reported.Patient's medical history includes allergies to iodine, iv contrast.No further complications were reported/anticipated.

• Brand Name: CENTERPIECE¿ PLATE FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
• 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21887617
• Report Number: 1030489-2025-01819
• Device Sequence Number: 3442589
• Product Code: NQW
• UDI-Device Identifier: 00763000552190
• UDI-Public: 00763000552190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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 Model Number: 8532065
• Device Catalogue Number: 8532065
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 82 KG