MAUDE Adverse Event Report: MENTOR TEXAS SMOOTH ROUND SPECTRUM® BREAST IMPLANT

Catalog Number	3501440
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) review is in progress.Once completed, the information will be submitted in a supplemental.(b)(4).
Event or Problem Description
It was reported that a customer received a mentor spectrum smooth round implant (catalog # 3501440, (b)(4)) without the injection dome, cap and 21 gauge needle.No patient consequence was reported.They opened another implant for the missing items and procedure was completed.

• Brand Name: SMOOTH ROUND SPECTRUM® BREAST IMPLANT
• Common Device Name: SMOOTH ROUND SPECTRUM® BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving 75038
• MDR Report Key: 6866929
• Report Number: 1645337-2017-00107
• Device Sequence Number: 93882
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3501440
• Device Lot Number: 7411747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1