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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 06/06/2017

Event Type  Injury  

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 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
• Type of Device: MIDFACIAL IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• Manufacturer (Section G): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• Manufacturer Contact: craig arthur ; 6025 nicolle street, suite b; ventura, CA 93003 ; 8053399415
• MDR Report Key: 6813367
• MDR Text Key: 83468596
• Report Number: 2028924-2017-00004
• Device Sequence Number: 1
• Product Code: LZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR