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

Model Number	016-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	03/23/2023
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 cranial mesh for a skull defect repair.It was reported that one year ago, the patient's left forehead surgical incision showed incision dehiscence, the titanium plate was slightly exposed, and the skin nutrition was poor.After contacting the hospital, surgery was recommended to remove the titanium plate.After careful consideration, the family requested conservative treatment.After treatment, the patient's condition progressively worsened and the exposure area of the left frontal titanium plate progressively expanded.The patient had been taking enalapril 10mg orally for a long time, about 12 years ago.The patient underwent intracerebral hematoma removal and decompressive craniectomy, and had a history of secondary epilepsy.Recently, the patient had taken levetiracetam tablets 0.25 once a night.Under general anesthesia, skull metal plate removal, epidural abscess excision and skin defect repair were performed.The operation went smoothly.After the operation, ecg monitoring, oxygen inhalation, nebulization, as well as hemostasis, anti-inflammatory and fluid replacement were given, so as to increase enteral nutrition, and regular dressing change for head surgery incision.
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.

• Brand Name: TIMESH ®
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona dr; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona dr; goleta CA 93117
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 20852311
• Report Number: 2021898-2024-00110
• Device Sequence Number: 18180713
• Product Code: HRS
• UDI-Device Identifier: 00643169620650
• UDI-Public: 00643169620650
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 016-200
• Device Catalogue Number: 016-200
• Device Lot Number: T181819
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/19/2024
• Date Device Manufactured: 02/28/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male