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Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Capsular Contracture (1761); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
This mdr is being reported as an individual event type for serious injury. Multiple attempts were made to contact the corresponding author for additional information, including relevant lot numbers. To date, no additional information has been obtained. The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed. Based on the reported information, a relationship between the event and strattice cannot be determined. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
Event Description
Capsular contracture is a common complication of breast augmentation surgery and many techniques to prevent and to treat capsular contracture have been suggested with inconsistent or variably effective results. The authors describe a protocol for treating established capsular contracture after breast augmentation with a low recurrence rate. From january 2009 to december 2012, 79 previous bilateral breast augmentation patients presented for treatment of established capsular contracture. There were 135 breasts with capsular contracture: 56 were bilateral and 23 were unilateral. Ten patients opted for no treatment; two patients opted for implant removal. Twenty-four were treated with the ices (implant exchange, capsulectomy, and possible exchange of site) protocol and 43 were treated with the spices (strattice placement in the reconstructive position, implant exchange, capsulectomy, and possible exchange of site) protocol. The 24 patients treated with the ices protocol had a recurrent capsular contracture rate of 15%. The 43 patients treated with the spices protocol had a 2. 7% recurrent capsular contracture incidence and an 2. 7% complication rate. Capsular contracture after breast augmentation, whether primary or recurrent, can be successfully treated with the spices protocol.
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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 Key9587476
MDR Text Key174927456
Report Number1000306051-2019-00136
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 health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
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 Received01/25/2020
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: 01/14/2020 Patient Sequence Number: 1