MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH DOUBLE Y PLATE, STANDARD; PLATE, BONE

Model Number	015-237
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
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 frontal cranial procedure on (b)(6) 2019, the doctor placed the plate but observed it was slightly bent so it did not fit correctly.The plate was removed and placed a different one that fit correctly.No patient impact was reported.
Additional Manufacturer Narrative
Result and conclusion evaluation codes updated.If information is provided in the future, a supplemental report will be issued.
Additional 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 eyelets was distorted and bent.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.¿ proteinaceous debris was observed on the surface of the plate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TIMESH DOUBLE Y PLATE, STANDARD
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8680783
• Report Number: 2021898-2019-00228
• Device Sequence Number: 16662247
• Product Code: JEY
• UDI-Device Identifier: 00643169620445
• UDI-Public: 00643169620445
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K973145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: 015-237
• Device Catalogue Number: 015-237
• Device Lot Number: T204622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 08/23/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 09/09/2019; 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1