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

Catalog Number 3501440

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2017

Event Type  malfunction  

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 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
• Type of Device: SMOOTH ROUND SPECTRUM® BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving 75038
• Manufacturer Contact: joaquin kurz ; 3041 skyway circle north; irving, TX 75038 ; 949789-383
• MDR Report Key: 6866929
• MDR Text Key: 86420231
• Report Number: 1645337-2017-00107
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 3501440
• Device Lot Number: 7411747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1