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	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One timesh plate was returned.One of the end eyelets was broken and deformed leaving a gap through the aperture.It is unknown how this damage occurred.The instructions for use cautions, ¿excess force, over-bending, notching, or scratching during mesh forming process could result in mesh fracture.¿ no other unusual characteristics were noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the skull repair surgery, the plate broke, and the screw broke in the middle.The products were replaced and there was no injury to the patient.
Additional Manufacturer Narrative
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: 8346250
• Report Number: 2021898-2019-00056
• Device Sequence Number: 1058068
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: T173885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 52