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

Model Number	015-018
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
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 patient was left with a right skull defect after undergoing "craniotomy and hematoma removal" under general anesthesia on (b)(6) 2022, due to trauma more than 2 years ago, and was admitted to hospital on (b)(6) 2024, for "open craniocerebral injury postoperative skull defect".After completing relevant examinations, the patient underwent skull defect repair on (b)(6) 2024.After the operation, they received symptomatic treatment with fluid infusion.Reexamination showed a small amount of fluid accumulation under the flap.The patient was transferred to the referral hospital on (b)(6) 2024, for continued rehabilitation treatment.On (b)(6) 2025, the titanium strip was found to be fractured.After evaluating the condition, a second surgery will be performed in the near future.
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
(b)(6) 2025 ared, cf (for, hcp): medtronic received information regarding a plate for cranial repair.It was reported that the patient was left with a right skull defect after undergoing "craniotomy and hematoma removal" under general anesthesia on (b)(6) 2022, due to trauma more than 2 years ago, and was admitted to hospital on (b)(6) 2024, for "open craniocerebral injury postoperative skull defect".After completing relevant examinations, the patient underwent skull defect repair on (b)(6) 2024.After the operation, they received symptomatic treatment with fluid infusion.Reexamination showed a small amount of fluid accumulation under the flap.The patient was transferred to the referral hospital on (b)(6) 2024, for continued rehabilitation treatment.On (b)(6) 2025, the titanium strip was found to be fractured.After evaluating the condition, a second surgery will be performed in the near future.

• 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 ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 21538722
• Report Number: 2021898-2025-00001
• Device Sequence Number: 7099224
• Product Code: HRS
• UDI-Device Identifier: 00643169620230
• UDI-Public: 00643169620230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062348
• 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,Followup
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 015-018
• Device Catalogue Number: 015-018
• Device Lot Number: T225070
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/18/2025
• Date Device Manufactured: 11/26/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 76 KG