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

Catalog Number	350-1490
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/20/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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).
Additional 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).
Additional 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).
Additional 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
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6434405
• Report Number: 1645337-2017-00017
• Device Sequence Number: 676278
• Product Code: FWM
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided; 10/21/2016; 10/21/2016; 10/21/2016
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/14/2017; 07/14/2017; 08/23/2017; 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 40 YR