MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ TH 755CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341454
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Wrinkling (2613)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
[safety_note_2] subject id:(b)(6).This event is associated with the glow clinical trial.It was reported that a female patient who underwent breast reconstruction primary surgery with mentor glow study gel devices on (b)(6) 2020.Adverse event # 6.Wrinkling, implant malposition,( left side, implant serial number: (b)(4).Doi: (b)(6) 2020).On (b)(6) 2020 (b)(6) 2021, she presented with wrinkling, implant malposition, which required pocket adjustment on (b)(6) 2021.The principal investigator assessed this event as mild in severity, serious, not related to the device, and unknown related to the procedure.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Reason for device explant and/or reoperation: device malposition, wrinkling.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.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ TH 755CC
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 16731907
• Report Number: 1645337-2023-04348
• Device Sequence Number: 6674076
• Product Code: FTR
• UDI-Device Identifier: 00081317024279
• UDI-Public: 00081317024279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 03/29/2025
• Device Model Number: 3341454
• Device Catalogue Number: 3341454
• Device Lot Number: 9441651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2020
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White