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

Model Number	8532067
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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 a bone screw used in laminoplasty therapy for neck pain.Levels implanted: c3-c7 it was reported that per the healthcare professional, when taking the screwdriver off the screw head, he believes that he may have torqued the driver and snapped the head off the screw in the driver.A fragment of the implant is remaining in the patient - a screw shank in c4 lateral mass.No additional surgery was required and an attempt to remove the implant was unsuccessful.No patient symptoms were reported.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: 21236341
• Report Number: 1030489-2025-00351
• Device Sequence Number: 13056026
• Product Code: NQW
• UDI-Device Identifier: 00763000552206
• UDI-Public: 00763000552206
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K212428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2025

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: 8532067
• Device Catalogue Number: 8532067
• 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: 06/20/2023
• Initial Report FDA Received Date: 01/25/2025
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 102 KG