MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	350-1490
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
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.(b)(4).The device was not received by mentor yet.
Event or Problem Description
It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery.By that time the patient was on the table.Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well.Additional information was obtained: the procedure was not canceled as the physician continued the procedure.However the delay caused a potential risk to the patient.The event required surgical intervention as the physician used a venous ports seal kit on the patient.Patient was required extended hospitalization.Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm).The patient is fine now.No other information was available about the patient.Device was sent back to mentor.
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.(b)(4).

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 33 technology drive; irvine CA 92618
• MDR Report Key: 6350753
• Report Number: 1645337-2017-00012
• Device Sequence Number: 17227469
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

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: 7377332-010
• Other Device ID Number: 350-1490
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 04/14/2017
• 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: Hospitalization; Required Intervention