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Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis Of Flap Tissue (1972); Seroma (2069); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
This literature review is being reported as an individual event type as serious injury due to the surgical intervention to treat the complications of infection, skin flap necrosis and seroma requiring reoperation. It is unknown if the strattice devices were explanted and whether patients in the strattice group required intervention for other complications. Multiple attempts are being made to contact the corresponding author to gather additional patient and procedure specific information including lot numbers and device dispositions. To date, the lot numbers associated with these events remain unknown; therefore, an internal investigation into the device history records could not be performed. No devices were returned to lifecell for evaluation. A relationship to the strattice could not be determined. If additional information is received, a follow up report will be submitted. No further actions are required as a nonconformance could not be confirmed.
Event Description
During a literature review, an article titled "a comparison of acellular dermal matrices in abdominal wall reconstruction" was identified which reported a review of all patients undergoing ab wall reconstruction (awr) between january 2003 and november 2016 at a single tertiary referral center for hernia recurrence and surgical site occurrence (sso) with the use of three different adms (strattice, alloderm and a non-allergan adm). This complaint is associated with complications in patients who received strattice adm. Of the 229 patients included, 98 received strattice. Complications reported for the strattice group include recurrence (10), delayed healing (24), skin necrosis (8), fistula (5), seroma (13), hematoma (3), and surgical site infection (23). Per the article, surgical site infections required antibiotics with or without reoperation. Seroma and hematomas included requiring drainage or reoperation. Delayed wound healing included wounds with prolonged requirement to heal or absence of surgical incision healing with or without the presence of dehiscence of previously healed incisions and/or skin necrosis. Necrosis included with or without infection that also required debridement. It should be noted that it is unclear whether patients in the strattice group had wound dehiscence and whether reoperation was required for other complications. Conclusions reported that acellular dermal matrices provide a durable repair with low overall rate of recurrence and complications in awr. The recurrence and complication profiles differ between brands. With proper patient selection and consideration, adms can be used confidently for a variety of indications and wound classifications.
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Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
MDR Report Key8289971
MDR Text Key134508468
Report Number1000306051-2019-00017
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/30/2019 Patient Sequence Number: 1