MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number 3505004BC |
Device Problems
Material Rupture (1546); Appropriate Term/Code Not Available (3191)
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Patient Problem
Deformity/ Disfigurement (2360)
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Event Date 02/27/2024 |
Event Type
Injury
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Manufacturer Narrative
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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: rupture.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).
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Event Description
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It was reported that a patient implanted with a 500cc mentor memorygel breast implant experienced a rupture on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2024.
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Manufacturer Narrative
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Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device visual analysis of the returned sample revealed that the smooth hpg, 500cc breast implant was found to have a tear on the anterior view, measuring approximately 0.1 cm.Additionally, an area of shell abrasion was observed on the edges of the tear.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Shell abrasion suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.A second product was received.No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).
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