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

Catalog Number	3501480
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/01/2023
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 is in progress.  once completed, a supplemental report will be submitted.D4: udi: as several of the device characteristics are unknown at this time, the udi is currently unavailable.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.  this report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.  this report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Reason for device explant and/or reoperation: deflation.Date of explantation: (b)(6) 2024.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision surgery with implantation of a 475cc mentor smooth round spectrum saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated left breast implant during a physical exam with a medical professional.As a result, the patient is scheduled for breast implant removal on (b)(6) 2024.
Additional Manufacturer Narrative
On september 03, 2024, mentor was notified that the patient injured her lefty breast when pushing a lawnmower in (b)(6) 2023.Shortly after she observed the deflated left breast.As an updated event date was provided, the event date is being updated.Date of event: august 01, 2023.The patient was also reported to have underwent bilateral removal and replacement with 325cc mentor smooth round moderate plus profile saline breast implants during the revision surgery.A photo of the suspect medical device was provided.An evaluation using the image was completed.Upon visual evaluation of the image provided in the complaint, the implant was observed deflated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 02, 2024, 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.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently unavailable.A partial udi is being submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 16, 2024, the mentor analysis lab received the suspect medical device for evaluation.On october 17, 2024, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection and leak testing of the device.Visual analysis of the returned sample revealed that the breast implant had a crease/fold extended from the anterior to the posterior view.Leak testing was performed, according to the mentor procedure, and it identified a tear within the crease/fold on the posterior view, measuring approximately 0.3 cm.The evaluation determined that the possible cause of the deflation was the trauma experienced.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Trauma is a known inherent risk of saline-filled mammary prosthesis.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19885108
• Report Number: 1645337-2024-08964
• Device Sequence Number: 12562519
• Product Code: FWM
• UDI-Device Identifier: 00081317002024
• UDI-Public: (01)00081317002024(11)020601(17)060630(10)245473
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 06/30/2006
• Device Catalogue Number: 3501480
• Device Lot Number: 245473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 09/03/2024; 10/16/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/12/2024; 09/23/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2002
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White