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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED N/A

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TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED N/A Back to Search Results
Catalog Number XXX-SURGIMEND
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information. (b)(4).
 
Event Description
Prs global open published (2017) "comparing the outcome of different biologically derived acellular dermal matrices in implant-based immediate breast reconstruction: a meta-analysis of the literatures". This study was designed to statistically analyze and discuss the outcome of 3 commonly used acellular dermal matrices (adms), alloderm (lifecell corp), strattice (lifecell corp), and surgimend (integra lifesciences - tei - boston)) in implant-based breast reconstruction. Method: comprehensive review of the literatures searched on electronic databases was done to identify studies published between 2006 and 2017 comparing the outcome of adms. Pooled random effect estimates for each complication and 95% confidence interval (ci) were calculated. Complications noticed for surgimend 174 / 912 ( surgimend complications / total number of cases). Major infection
=
32 , eichler c et al (2015) - 3, gaster richard s (2013) - 1 , ricci ja et al (2016) - 23 , ball et al (2017) - 5. Minor infection
=
38, eichler c et al (2015) - 4, eichler c et al (2017) - 1 , butterfield jl (2013) - 17 , ricci ja et al (2016) - 12 , ball et al (2017) - 4. Seroma
=
42, eichler c et al (2015) - 1, butterfield jl ( 2013) - 30 , ricci ja et al (2016) - 7, ball et al (2017) - 4. Hematoma
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11: eichler c et al (2017) - 1 ; butterfield jl (2013) - 4; ricci ja et al (2016) - 5 ; ball et al (2017) - 1. Implant loss
=
41: butterfield jl (2013) - 29; ricci ja et al (2016) - 10 ; ball et al (2017) - 2. Localized inflammation
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10: eichler c et al (2015) - 3; eichler c et al (2017) - 3; ball et al (2017) - 4. Results: twenty-one studies met the inclusion with a total of 1,659, 999, and 912 breasts reconstructions in alloderm, strattice, and surgimend, respectively. Seven complications extracted including major and minor infection, seroma, implant loss, hematoma, capsular contracture, and localized erythema. Pooled total complication rates were 23. 82% in strattice, 17. 98% in surgimend, 16. 21% in alloderm. Seroma rate was the highest in strattice group (8. 61%). There was no statistical significance between and within groups. Conclusion: although strattice exhibited a higher overall pooled complication rate compared with alloderm and surgimend, the incidence of individual complication varies between studies. A cost analysis of different adms may aid in choosing the type of adms to be used.
 
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Brand NameSURGIMEND MATRIX - UNSPECIFIED
Type of DeviceN/A
Manufacturer (Section D)
TEI BIOSCIENCES INC
7 elkins street
7 elkins street
boston MA 02127
Manufacturer (Section G)
TEI BIOSCIENCES INC
7 elkins street
boston MA 02127
Manufacturer Contact
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8214870
MDR Text Key132232354
Report Number3004170064-2019-00004
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K071807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-SURGIMEND
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 Received01/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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