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 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the doctor used the matching screw to the plate being used to break into the skull, the plate's hole was broken and could not be used normally.The operation was completed after replacing with the same type of product.The patient's status at the time of the report was alive-no injury.

Manufacturer Narrative

One timesh plate was returned.The plate was not attached to the tag with the part number and lot number information.One of the end eyelets was broken and left a gap through the aperture.It is unknown how this damage occurred.The instructions for use cautions, ¿excessive force, over-bending, notching, or scratching during mesh forming process could result in 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8400432
• MDR Text Key: 138138206
• Report Number: 2021898-2019-00093
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• 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: T194583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• 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
• Patient Age: 64 YR