MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH RIGID CRANIAL MESH; PLATE, BONE

Model Number	016-152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient developed an infection after implant of the plate.It was stated the plate needed to be shaped prior to implant and the shaping factory was a domestic plastic factory.The plate was explanted due to the infection.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the cause of the head wound infection was not determined.It was stated the patient still currently had a skull defect present and did not undergo a skull repair operation.

• Brand Name: TIMESH RIGID CRANIAL MESH
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7412880
• Report Number: 2021898-2018-00187
• Device Sequence Number: 1636723
• Product Code: JEY
• UDI-Device Identifier: 00613994284648
• UDI-Public: 00613994284648
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 016-152
• Device Catalogue Number: 016-152
• Device Lot Number: T166481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 59