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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILTEX ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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MENTOR SILTEX ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Model Number 3542420M
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code Deformity/ Disfigurement (2360)
Date of Event 08/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
 
Event or Problem Description
It was reported that a female who underwent an unknown breast augmentation reconstruction with a mentor siltex round spectrum, 175cc breast implant experienced unknown-sided deflation post procedure.As a result patient underwent an explant on (b)(6)2 021.
 
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Brand Name
MENTOR SILTEX ROUND SPECTRUM
Common Device Name
PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
MDR Report Key12682163
Report Number1645337-2021-11799
Device Sequence Number11821812
Product Code FWM
UDI-Device Identifier00081317002062
UDI-Public00081317002062
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P990075
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year1996
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/26/2021
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 Model Number3542420M
Device Catalogue Number3542420M
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/26/2021
Initial Report FDA Received Date10/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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 Number1
Outcome Attributed to Adverse Event Required Intervention;
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