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	09/04/2019
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 when the patient finished the fixation of the skull, it was necessary to use the cranio-maxillofacial fixation system.When the fixation screw was fixed, the fixation hole on the plate of the system broke.It was noted that the broken fragments did not fall into the brain.The doctor replaced the plate with a new one.

• 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: 9349435
• Report Number: 2021898-2019-00417
• Device Sequence Number: 2734252
• Product Code: JEY
• UDI-Device Identifier: 00673978002682
• UDI-Public: 00673978002682
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973145
• 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
• Report Date (Section B): 11/20/2019

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: T168013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR