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	12/26/2024
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 during inspection upon the arrival of the purchased good, it was found that the product was kinked.No patient involvement.
Additional Manufacturer Narrative
H3.Product analysis determined that the visual inspection confirmed the plate had been bent possibly during the shipping process since the part was still packaged.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: TIMESH®
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 4620 n. beach st.; fort worth TX 76137
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 4620 n. beach st.; fort worth TX 76137
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 21025691
• Report Number: 2021898-2024-00111
• Device Sequence Number: 8191525
• Product Code: HRS
• UDI-Device Identifier: 00643169620278
• UDI-Public: 00643169620278
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: 015-042
• Device Catalogue Number: 015-042
• Device Lot Number: T221072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• 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: Unknown