MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. BINDER SUBMALAR (R) IMPLANT; MALAR IMPLANT

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed sterilization records, manufacturing records, and product labeling.Results: no failure was detected.Conclusion: the possibility of infection is a known, inherent risk associated with implant surgery.
Event or Problem Description
Complainant reported that patient complained of left cheek tenderness and had left side cheek implant explanted due to infection approximately 3 months post-operatively.No culture was taken, so no organism has been identified.As of (b)(6) 2017, physician felt infection appears to be resolved.Note: the complainant reported that rhinoplasty, neck lift, lip lift, mandible and forehead contouring with brow lift and scalp advancement were cited as concomitant medical therapies.

• Brand Name: BINDER SUBMALAR (R) IMPLANT
• Common Device Name: MALAR IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 6923692
• Report Number: 2028924-2017-00006
• Device Sequence Number: 19037262
• Product Code: LZK
• UDI-Device Identifier: M724BSMM1
• UDI-Public: M724BSMM1
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K894493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: Physician
• Device Expiration Date: 12/07/2021
• Device Model Number: N/A
• Device Catalogue Number: BSM-M
• Device Lot Number: 869223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/06/2017
• 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: Required Intervention
• Patient Age: 34 YR