MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. GLUTEAL IMPLANT, ROUND, TEXTURED, SDM

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method: the actual device was returned and gross visual examination and examination under magnification was performed.A review of manufacturing records and quality control records was also performed.Results: code for "none" selected as no more appropriate code was located.A tear in the circumference of the device was observed.Conclusion: breakage or damage to medical devices on implantation is a known risk of the procedure.Product labeling warns that a prosthesis that appears damaged should not be implanted.
Event or Problem Description
Complainant reported that they received a gluteal implant that contained bubbles.They proceeded to insert the implant into a keller funnel, and it ripped.The problem occurred before there was any patient contact, and they had a backup available so there was no impact to the patient.

• Brand Name: GLUTEAL IMPLANT, ROUND, TEXTURED, SDM
• Common Device Name: GLUTEAL IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 7219175
• Report Number: 2028924-2018-00001
• Device Sequence Number: 18871530
• Product Code: MIB
• UDI-Device Identifier: M724CCB6T841
• UDI-Public: M724CCB6T841
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/06/2022
• Device Model Number: N/A
• Device Catalogue Number: CCB6-T-84
• Device Lot Number: 873720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1