MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. FLOWERS EXTENDED TEAR TROUGH (R) IMPLANT; MIDFACIAL IMPLANT

Model Number	N/A
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	06/06/2017
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 abscess and infections is a known, inherent risk associated with implant surgery.
Event or Problem Description
Patient reported developing abscess and infection in sinus after receiving implantech tear trough implant and suprafoil implant which she received to treat area affected by trauma.(note: the suprafoil implant, manufactured by f.Jackson, inc in (b)(4), is not known by implatech to be commonly used in conjunction with our implants.) patient had surgery to drain and scrape the affected area approximately 3 months post-operatively.Patient has received multiple courses of antibiotics (cipro p.O.).Patient and current treating physicians have verified that symptoms associated with infection have resolved and antibiotics have been discontinued.(note: implanting physician has been listed as the reporter, however patient received latest follow-up from another physician.).

• Brand Name: FLOWERS EXTENDED TEAR TROUGH (R) IMPLANT
• Common Device Name: MIDFACIAL IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 6813367
• Report Number: 2028924-2017-00004
• Device Sequence Number: 1041971
• Product Code: LZK
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K921582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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: Health Professional
• Device Expiration Date: 01/10/2022
• Device Model Number: N/A
• Device Catalogue Number: EFTT-L
• Device Lot Number: 869534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/23/2017
• 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: 25 YR