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 11/28/2018

Event Type  malfunction  

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 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.

Manufacturer Narrative

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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8346250
• MDR Text Key: 136770869
• Report Number: 2021898-2019-00056
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00673978002682
• UDI-Public: 00673978002682
• 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: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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
• Patient Age: 25 YR
• Patient Weight: 52