MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CENTERPIECE PLATE FIXATION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8530630
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional(hcp) via a manufacturer representative regarding a device used in laminoplasty.It was reported that when the insertion of that screw was started under a microscope, it was noticed that a small piece of metal was attached to the screw head, and that screw was not used.It was replaced with a new screw of the same size and placed inside the patient's body.Preoperative diagnosis of this surgery was cervical spondylotic myelopathy.The level at which the implant was performed: c3/6.There was a delay of less than 60 minutes.There was no patient symptom in the event and no further complications/symptoms were reported.Additional information was received from the manufacturer representative that the there is a possibility that the metal fragment is part of the driver.When attached to the screw driver and carried to the surgical field, a piece of metal was attached to the implant screw head on the right side of the screwdriver.Therefore, it was not used.
Additional Manufacturer Narrative
G2: the country of the event is japan.H3.Device evaluation summary: product analysis # (b)(4): lot# ca16d227, visual and functional testing identified that the tip of the instrument is worn from what appears to be repeated normal use.This is consistent with anticipated wear.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CENTERPIECE PLATE FIXATION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21340132
• Report Number: 1030489-2025-00640
• Device Sequence Number: 14392348
• Product Code: LXH
• UDI-Device Identifier: 00885074540702
• UDI-Public: 00885074540702
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2025

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: 8530630
• Device Catalogue Number: 8530630
• Device Lot Number: CA16D227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown