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

Model Number	N/A
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Multiple Organ Dysfunction Syndrome (3261)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: method: the actual device was not evaluated, however manufacturing (assembly & packaging) records were reviewed, sterilization process records were reviewed, labeling was evaluated.Results: no failure was detected.Conclusion: the possibility of infection-like symptoms are known, inherent risks of implant surgery.Labeling also discusses the possibility of explant surgery taking place at any time after implantation.
Event or Problem Description
Complainant reported that patient who received gluteal implants had to have devices explanted bilaterally nine days post-operatively due to signs of infection and apparent organ failure.Patient started to experience problem fairly soon after implantation.When seen 1 week post-op, patient had secretions, pus and foul odor which led reporting physician to think there was an infection.Culture was taken which ended up having a negative result.Patient continued to get worse and appear to develop organ failure (kidney, etc.) another culture was taken and again the results were negative.Reporting physician considered the possibility of sepsis, but the results of all the cultures taken failed to support presence of any bacterial infection.After removal, the patient's symptoms have resolved.

• Brand Name: CONTOURFLEX(TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP)
• Common Device Name: CONTOURED CARVING BLOCK IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle st., suite b; ventura,
• MDR Report Key: 7538909
• Report Number: 2028924-2018-00005
• Device Sequence Number: 1794416
• Product Code: MIB
• UDI-Device Identifier: M724CCB631
• UDI-Public: M724CCB631
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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: 01/19/2023
• Device Model Number: N/A
• Device Catalogue Number: CCB6-3
• Device Lot Number: 875467
• 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: 05/11/2018
• Initial Report FDA Received Date: 05/23/2018
• 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: 40 YR