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It was reported that a patient implanted with two 255cc mentor memorygel xtra breast implant experienced bilateral capsular contracture (baker grade 3) post-operatively.As a result, the patient underwent explantation on (b)(6) 2025.As a result, the patient underwent explantation on month xx, 2025.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Dhr/mfg/exp, pending adverse event review activity, pending analysis or repair closure, closure, verify quarterly re-op note.3500a initial report (xxx) was submitted to the fda on october 15, 2025.3500a supplemental report (xxx) was submitted to the fda on october 15, 2025.Mentor became aware the patient would undergo explantation on (b)(6) 2025.Mentor received a confirmed date of explant.Relevant fields have been updated.Section d6b, date of explant: (b)(6) 2025.The mentor failure analysis lab 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.On december 10, 2024, the mentor failure analysis lab received the device for evaluation.On september 5, 2025, mentor completed evaluation of the device.Device evaluation summary: unknown gel implants, prosthesis, breast, noninflatable, internal, silicone gel-filled, unknown saline implants, prosthesis, breast, inflatable, internal, saline, unknown tissue expanders, lcj, expander, skin, inflatable.H6 health effect - clinical code e2402: mentor was provided two serial numbers (xx/xx) but it is unknown which serial was the impacted device.If further information is received, a supplemental will be sent.A lot number was provided but does not correspond to any finished good.As a result, a dhr review cannot be completed.Should an updated/accurate lot number be received, a supplemental report will be sent.It was reported that a product was found to be problem 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.(b)(4) was properly received by the fda, but due to a technical issue, returned a 'data error' in ecm.Reference attached xml for ack 3.Mentor became aware that a discrepancy was observed when the information reported included a date of implantation that occurred prior to the manufacturing date of the breast implant.If new information becomes available, mentor will submit a supplemental report.One product was received by the mentor failure analysis lab on month xx, 2024 with no accompanying information.The device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, the return of a prosthesis is characteristic of a removal and replacement surgery.As a result, this will be conservatively reported to fda.It is unknown if the patient¿s device was a gel or saline device.In the absence of clarifying information, the device will be reported with sections d2a and d2b indicating a gel device.If additional information is received confirming gel or saline, a supplemental report will be sent.Crf: demographics section - patient information, surgery section - device info, adverse event details section - adverse events, secondary procedures section - details on any secondary procedures.Harmonized procedures: 100673617 - franchise intake process, 100673618 - franchise file processing, regulatory determination and activity management, 100673621 - franchise business data administration (training matrices here), 100673622 - franchise complaint end-to-end in-process metrics targets and loc closure metrics, 100673625 - franchise us fda individual medical device reporting (mdr), 100673626 - franchise product investigation, 100538251 - franchise complaint handling procedure, 100538246 - franchise complaint awareness procedure, 100708316 - franchise business continuity plan ecm, 100673620 - franchise complaint handling glossary, 100292506 - franchise procedure for management of shared documents, 100648144 - franchise work instructions for shared document process, 100823766 - franchise procedure on management of customer quality data.Other (localized) documents: dop-qa-4007 - product complaint handling, dop-qa-4015 - product analysis, 100559123 - mentor regulatory reporting, 100553401 - mentor product experience codes table, 100553403 - mentor patient codes table, 100396405 - mentor medical assessment for complaints , 100254122 - nc procedure, 100400282 - harms map, 100553401 - pec table, 100553403 - pc table, (b)(4) - pia/qrb, (b)(4) - escalation procedure.Device to be returned / dhr received 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: 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: device to be returned / dhr not received 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.Reason for device explant and/or reoperation: 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: device to be returned / lot # unknown 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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: 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: device implanted / dhr received 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 (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: no information regarding explantation or an expected explantation date has been received.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: device implanted / dhr not received 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: no information regarding explantation or an expected explantation date has been received.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: device implanted / lot # unknown 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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: no information regarding explantation or an expected explantation date has been received.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: device returned / dhr received / analysis incomplete 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.Reason for device explant and/or reoperation: 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: device returned / dhr not received / analysis incomplete 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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: 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:.
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