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

Model Number	FXS19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Date of Event	08/18/2016
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 experienced a pain and wound dehiscence leading to fenix device explant.The fenix device was used as part of the surgical procedure.Surgical procedure and device implant on (b)(6) 2016.Patient was monitored for pain and prophylactically treated with antibiotics.Patient received iv antibiotics 13 days after implant and patient reported symptoms of constipation and pain.Device explant through surgical site on (b)(6) 2016 due to pain and would dehiscence.Physician reported that during device explant the device got hung up on a ligament.A clamp was applied to each end of the cut device and a "great deal of force" was applied; enough to break a device connecting wire.Device was found in the correct position at time of explant.Patient is recovering well.
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 experienced a pain and wound dehiscence leading to fenix device explant.The fenix device was used as part of the surgical procedure.-surgical procedure and device implant on (b)(6) 2016.-patient was monitored for pain and prophylactically treated with antibiotics.-patient received iv antibiotics 13 days after implant and patient reported symptoms of constipation and pain.-device explant through surgical site on (b)(6) 2016 due to pain and wound dehiscence.-physician reported that during device explant the device got hung up on a ligament.A clamp was applied to each end of the cut device and a "great deal of force" was applied; enough to break a device connecting wire.-device was found in the correct position at time of explant.-patient is recovering well.

• Brand Name: FENIX CONTINENCE RESTRORATION SYSTEM
• Common Device Name: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 6064941
• Report Number: 3008766073-2016-00076
• Device Sequence Number: 75476
• Product Code: PMH
• UDI-Device Identifier: 00855106005523
• UDI-Public: 00855106005523
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: H130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2017

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: 02/04/2020
• Device Model Number: FXS19
• Device Lot Number: 10061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2016
• Supplement Report FDA Received Date: 04/13/2017
• 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; Other
• Patient Age: 38 YR