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

Model Number	Size: 14.9cm x 14.9cm x 3.9cm
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Seroma (2069)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: though the device was not returned, implantech performed a review of the production records.(no errors or omissions were identified that might account for the reported events.) no other reports of seromas or infection have been reported on this lot or associated sterile lot.Complaint rates remain low, and no increase in the frequency or severity of the devices has been identified.Results: no device problem was identified via review of the production records.There have been no other reports of seroma or infection with either the manufacturing lot or associated sterile lot.Conclusion: seromas and infection are known inherent risks of implant procedures and are addressed in the product labeling.
Event or Problem Description
Complainant reported that patient had left side gluteal implant diagnosed with recurring seromas and infection.Organism was identifed as mycobacterium avium.Patient has received multiple courses of oral antibiotics.(this constitutes the report for the left side device.Refer to 2028924-2023-00003 for report on the right side device involved in the same event and on the same patient).

• Brand Name: CONTOURFLEX (TM) GLUTEAL IMPLANT TEXTURED (ROUND)
• Common Device Name: CONTOURED CARVING BLOCK 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: 16725256
• Report Number: 2028924-2023-00004
• Device Sequence Number: 7949991
• Product Code: MIB
• UDI-Device Identifier: M724CCB5T531
• UDI-Public: M724CCB5T531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: 04/09/2026
• Device Model Number: Size: 14.9cm x 14.9cm x 3.9cm
• Device Catalogue Number: CCB5-T-53
• Device Lot Number: 892575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female