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Model Number SMXP130RH |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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During the visual evaluation, a tear was noted in the anterior patch, measuring approximately 0.7 cm.Additionally, an area of missing material measuring approximately 1.2 cm x 1.4 cm was noted at the junction at the shell and patch.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.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Reason for device explant and/or reoperation: ni.Manufacturer¿s reference number: (b)(4).
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Event Description
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On (b)(6) 2020, a 475cc artoura breast tissue expander that was returned to mentor for analysis was found to be deflated.The reason for explant was not provided, but with the information available, it was determined that the device was explanted as part of a staged reconstruction.A 375cc mentor memorygel device was implanted in its place (catalog # 3503751bc, s/n (b)(4)).There were no reports of any device issue or patient consequence, and multiple follow-up attempts were made without receiving a response.Mentor will report this event based on the analysis findings, and if any additional information is received in the future, a supplemental report will be submitted.This report is for the patient¿s left-sided device.
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Search Alerts/Recalls
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