MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. CONTOURFLEX (TM) GLUTEAL IMPLANT, ROUND; CONTOURED CARVING BLOCK

Model Number	N/A
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: the actual device was not evaluated, however implantech performed sterilization review, manufacturing review, and labeling evaluation.Results: no failure was detected.Conclusions: infection is a known, inherent risk of implant procedures.
Event or Problem Description
Complainant reported that patient had gluteal implants explanted bilaterally approximately 17 days post-operatively due to infection.The patient presented with pain, redness, swelling and slight necrosis on the right side 10 days post-operatively and was prescribed a 10 day course of clindamycin po.When issues did not appear to be resolving as fully as desired, the decision was made to explant the devics.A culture was taken, and results found citrobacter braakii.Patient has significant medical history of being pre-diabetic and being (b)(6) since 2002.Physician's office cited poor patient after care as one reason for the event, and initially did not feel devices caused or contributed to the event.Subsequent f/u with complainant indicated that device involvement could not be ruled out, hence implantech has elected to report this event.

• Brand Name: CONTOURFLEX (TM) GLUTEAL IMPLANT, ROUND
• Common Device Name: CONTOURED CARVING BLOCK
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 7360090
• Report Number: 2028924-2018-00002
• Device Sequence Number: 1273700
• Product Code: MIB
• UDI-Device Identifier: M724CCB541
• UDI-Public: M724CCB541
• Combination Product (Y/N): N
• PMA/510(K) Number: K052504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: 01/09/2023
• Device Model Number: N/A
• Device Catalogue Number: CCB5-4
• Device Lot Number: 875177
• 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: 02/21/2018
• Initial Report FDA Received Date: 03/21/2018
• 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: 65 YR