MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. CONTOURFLEX (TM) TEARDROP GLUTEAL IMPLANT

Model Number	N/A
Health Effect - Clinical Codes	Failure of Implant (1924); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed manufacturing records, sterilization records, and product labeling.Results: no failure was detected.Conclusion: the possibility of serous fluid accumulation and/or infection are known, inherent risks associated with implant surgery.
Event or Problem Description
Complainant reported that patient who had implantech gluteal implants placed in the calf region bilaterally, subsequently developed serous fluid accumulation in the area of the right side implant.Patient had the area drained repeatedly starting approximately 2 months post-operatively.For the next 21 months, the patient had the area drained repeatedly and took several courses of oral antibiotics, as well.The patient had the right side device explanted approximately 23 months post-operatively.Complainant reported that cultures taken 3 weeks before explant and on the day of the explant came back negative.There was a culture taken from the patient about 8 days after the explant surgery, and psuedomonas aeruginosa was identified.In latest follow up with complainant, patient's infection appears to be resolved, however patient has not scheduled any replacement.

• Brand Name: CONTOURFLEX (TM) TEARDROP GLUTEAL IMPLANT
• Common Device Name: GLUTEAL IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 6311439
• Report Number: 2028924-2017-00002
• Device Sequence Number: 18938770
• Product Code: MIB
• UDI-Device Identifier: M724CCB611
• UDI-Public: M724CCB611
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: 06/01/2018
• Device Model Number: N/A
• Device Catalogue Number: CCB6-1
• Device Lot Number: 850515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/08/2017
• 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: 51 YR