MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number 350-1490

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

The mentor failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants.During routine set up, the physician found that the package of the implant did not contain the dome pack accessory.The physician requested for another mentor spectrum package; however, two additional packages also were missing the dome.The physician had to put tissue expanders instead and schedule an additional surgery.This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery.

Manufacturer Narrative

On march 27, 2017, mentor worldwide llc has initiated a voluntary remedial action to remove one (1) lot of mentor® saline-filled spectrum¿ breast implants (575cc) lot number 7377332.Some units in the affected lot do not contain the dome pack accessory indicated on the box label.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

This report is to correct supplemental follow-up #2 (report # 1645337-2017-00017).Date of this report on 3500a initial report was correct.Date of this report is (b)(6) 2016.(b)(4).

Manufacturer Narrative

Device evaluation summary: it was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants.During routine set up, the physician found that the package of the implant did not contain the dome pack accessory.The returned device was not shipped with its box or thermoform.However, the check valve and tubing were received.The device appeared clean and intact.The dome was not received with the rest of the device components.The customer complaint is confirmed.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Date of this report on 3500a initial report.The correct date is 03/24/2017.(b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: joaquin kurz ; north irving, TX 75038-3540 ; 9497893837
• MDR Report Key: 6434405
• MDR Text Key: 70858993
• Report Number: 1645337-2017-00017
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/21/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 350-1490
• Device Lot Number: 737733-011
• Other Device ID Number: 350-1490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; 10/21/2016; 10/21/2016; 10/21/2016
• Supplement Dates FDA Received: 04/14/2017; 07/14/2017; 08/23/2017; 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR