MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH 1X PLATE, BURR HOLE COVER; PLATE, BONE

Model Number	015-262-18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
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 the holes on the plate were broken at the connector.The plate was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
Patient weight updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TIMESH 1X PLATE, BURR HOLE COVER
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7061959
• Report Number: 2021898-2017-00597
• Device Sequence Number: 2144366
• Product Code: JEY
• UDI-Device Identifier: 00673978003481
• UDI-Public: 00673978003481
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2017

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: 015-262-18
• Device Catalogue Number: 015-262-18
• Device Lot Number: T163315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 69