MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS, LLC ULTRATINE FOREHEAD 3.0

Model Number	CFD-23202
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record associated with part# cfd-23202/lot# 343949 was reviewed and there were no anomalies identified which would result in the reported issue.A review of the device's complaint history has revealed that this product is performing as expected, with regard to the reported failure mode.Multiple follow-ups have been made to the customer for information related to the reported event and results of the revision surgery.If additional information is received, this record will be updated.With the information available it is not possible to determine the cause of the reported issue.It is possible that the surgeon inadvertently sheared off one of the device's compression flanges by attempting to implant it at an off-axis angle.This would result in incomplete anchoring of the device and could result in the device becoming dislodged from the hole drilled for it.
Event or Problem Description
A customer has reported that a patient was implanted with ultratine in (b)(6) 2020.The patient later contacted the surgeon to report that the device had started to dislodge from the hole drilled for it.A subsequent appointment has been scheduled for a possible revision surgery.
Additional Manufacturer Narrative
On july 16th, 2020, microaire was notified that the patient associated with mdr# 2020601-2020-00004 has opted not to pursue a revision surgery.

• Brand Name: ULTRATINE FOREHEAD 3.0
• Common Device Name: ULTRATINE FOREHEAD 3.0
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville, va
• MDR Report Key: 10247346
• Report Number: 2020601-2020-00004
• Device Sequence Number: 19035311
• Product Code: HWC
• UDI-Device Identifier: 00847399006882
• UDI-Public: 00847399006882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: No Information
• Device Expiration Date: 10/03/2021
• Device Model Number: CFD-23202
• Device Catalogue Number: CFD-23202
• Device Lot Number: 343949
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 59