MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE; ENDOTINE FOREHEAD 3.5

Model Number CFD-22102

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 12/13/2012

Event Type  Injury  

Event Description

Loss of fixation.At two days following the original surgery, the lifted area had dropped.Upon performing a second surgery, it was confirmed that the implant had broken.Submitting report due to indication of intervention / second surgery required.Note: the original complaint regarding the occurrence was opened on (b)(6) 2013 when microaire first became aware of the occurrence, and was closed on (b)(6) 2013.Upon recent review of complaints from past years, it was discovered that tis item should have been reported to fda.Therefore, we are submitting report at this time.

Manufacturer Narrative

Based on indication that a second surgery was required to be performed, it was determined that this occurrence is reportable.

• Brand Name: MICROAIRE
• Type of Device: ENDOTINE FOREHEAD 3.5
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer Contact: todd moore ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758000
• MDR Report Key: 4118049
• MDR Text Key: 17993864
• Report Number: 2020601-2014-00008
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K032770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2015
• Device Model Number: CFD-22102
• Device Catalogue Number: CFD-22102
• Device Lot Number: 153388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention