MAUDE Adverse Event Report: TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM; IMPLANTED FECAL INCONTINENCE DEVICE

Model Number	FXS16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have fenix beads eroded through the anal canal leading to fenix device explant.The fenix device was used as part of the surgical procedure.-uneventful surgical procedure and device implant on (b)(6)2017; 3-4 vessels were stitched during the implant procedure to decrease bleeding.-the patient presented with discharge and tenderness; during a digital rectal exam the device was found to have eroded into the anterior rectum on (b)(6)2017.Symptoms began (b)(6)2017.-uneventful device explant (b)(6)2017 due to 2 fenix device beads found eroded through the anal canal; an infection was present at the exposure site.The fenix device was removed transanally.The device was intact at the time of explant.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have fenix beads eroded through the anal canal leading to fenix device explant.The fenix device was used as part of the surgical procedure.Uneventful surgical procedure and device implant on (b)(6) 2017; 3-4 vessels were stitched during the implant procedure to decrease bleeding.The patient presented with discharge and tenderness; during a digital rectal exam the device was found to have eroded into the anterior rectum on (b)(6) 2017.Symptoms began (b)(6) 2017.Uneventful device explant (b)(6) 2017 due to 2 fenix device beads found eroded through the anal canal; an infection was present at the exposure site.The fenix device was removed transanally.The device was intact at the time of explant.The patient was reported as doing well after removal.

• Brand Name: FENIX CONTINENCE RESTORATION SYSTEM
• Common Device Name: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 6802365
• Report Number: 3008766073-2017-00095
• Device Sequence Number: 16314881
• Product Code: PMH
• UDI-Device Identifier: 00855106005493
• UDI-Public: 00855106005493
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H130006
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/16/2020
• Device Model Number: FXS16
• Device Lot Number: 10522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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; Disability
• Patient Age: 76 YR