MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH STRAIGHT PLATE 1H X 1H 8 MM; PLATE, BONE

Model Number	015-042
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
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 during the surgery, the plate was broken and couldn't be used normally.The procedure was completed with backup product(s).The patient's status at the time of the report was alive-no injury.

• Brand Name: TIMESH STRAIGHT PLATE 1H X 1H 8 MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9788045
• Report Number: 2021898-2020-00078
• Device Sequence Number: 2650373
• Product Code: JEY
• UDI-Device Identifier: 00643169620278
• UDI-Public: 00643169620278
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 015-042
• Device Catalogue Number: 015-042
• Device Lot Number: T214705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR