MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3501430
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: material rupture.(b)(4).
Event or Problem Description
It was reported that a female patient, who underwent breast reconstruction with a 225cc mentor smooth round spectrum saline breast prosthesis on the left side, suffered left breast implant deflation, post-procedure.The deflation was diagnosed via visual examination.As a result, the patient underwent bilateral removal and bilateral replacement with two unspecified mentor saline breast prostheses on (b)(6) 2020.The patient was in stable condition after the surgery.
Additional Manufacturer Narrative
On december 15, 2020, the mentor failure analysis lab received the device for evaluation.On december 22, 2020, the product investigation was completed.Device investigation summary: during visual evaluation, an anomaly was observed on the device consistent with a crease/fold on the posterior view.A tear was also observed within the crease/fold measuring approximately 3.5 cm.The evaluation determined that the loss of shell integrity is consistent with a crease fold deflation of the implant shell, which is a known inherent risk of saline-filled mammary prosthesis.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in a deflation in a later time.Breast implants may also simply wear out over time.A second product was received (lot-7671251).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10880368
• Report Number: 1645337-2020-14928
• Device Sequence Number: 2863686
• Product Code: FWM
• UDI-Device Identifier: 00081317001973
• UDI-Public: 00081317001973
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: 3501430
• Device Catalogue Number: 3501430
• Device Lot Number: 7342913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: 36 YR