MENTOR TEXAS MENTOR MEMORYGEL BOOST BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
|
Back to Search Results |
|
Catalog Number SHPB370 |
Device Problems
Material Deformation (2976); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/18/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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.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: pc-001558314.
|
|
Event Description
|
It was reported that a 370cc mentor memorygel boost breast implant was found to contain shell irregularities during an operation.No adverse event was experienced by the patient.The surgeon used backup devices, and there were no reported patient consequences or procedural delays.
|
|
Manufacturer Narrative
|
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned device determined that an excess material was embedded on the shell of the smo ro high pro boost gel370cc breast implant, measuring approximately 0.1 x 0.1 cm on the anterior view.Additionally, the breast implant was received without its sealed thermoform.Leak testing was performed, according to mentor procedure, no gel exposure was detected on the analysis.Based on the information currently available, a notification was sent to mentor's manufacturing team for further investigation.According to the manufacturing investigation, the evaluation of process controls took into account the defect mentioned in the product complaint, from observing the complaint device, the defect of the device is classified as excess material on the shell that does not render the patch seal non functional but may be visible to the user.In response to this finding, awareness training was provided to all final inspection operators and assembly operators for awareness and reinforcement of the confirmed manufacturing defect.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).
|
|
Search Alerts/Recalls
|
|
|