MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH®; PLATE, FIXATION, BONE

Model Number	015-042
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Medtronic received information regarding a plate for cranial repair.It was reported that the surgeon used the craniomaxillofacial fixation system to install a 2-hole 8mm standard straight plate.The first screw was screwed in normally.After the second screw was screwed in, it was found that the connection plate was broken.The broken part was immediately removed, and the circulating nurse replaced the craniomaxillofacial fixation system, which the surgeon used normally.

• Brand Name: TIMESH®
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 4620 north beach street; fort worth TX 76137
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 4620 north beach street; fort worth TX 76137
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20407483
• Report Number: 2021898-2024-00105
• Device Sequence Number: 14297646
• Product Code: HRS
• UDI-Device Identifier: 00673978002668
• UDI-Public: 00673978002668
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 10/09/2024

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: 015-042
• Device Catalogue Number: 015-042
• Device Lot Number: T245597
• 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: 10/09/2024
• Initial Report FDA Received Date: 10/09/2024
• Date Device Manufactured: 10/18/2021
• 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: 13 YR
• Patient Sex: Female