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

Model Number 015-044

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine,ca, MN 92618 ; 7635263305
• MDR Report Key: 8680521
• MDR Text Key: 147457922
• Report Number: 2021898-2019-00225
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00643169620292
• UDI-Public: 00643169620292
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1