MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH 1 X PLATE, STRAIGHT; PLATE, BONE

Model Number	015-044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent cranioplasty on (b)(6) 2019 due to a tumor.During the operation, the device's hole fractured.It was stated that it was replaced with another device on site.It extended the procedure by 10 minutes.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned timesh plat was bent in half.The tab was not returned with the device.One of the eyelets was distorted and broken.It is unknown how or when this damage occurred.The instructions for use cautions, ¿excess force, over-bending, notching, or scratching during mesh forming could result in a mesh fracture.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: TIMESH 1 X PLATE, STRAIGHT
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8680521
• Report Number: 2021898-2019-00225
• Device Sequence Number: 13863999
• Product Code: JEY
• UDI-Device Identifier: 00643169620292
• UDI-Public: 00643169620292
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 015-044
• Device Catalogue Number: 015-044
• Device Lot Number: T190001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1