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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.
 
Event Description
Ps journal published (2017) "the comparison of strattice and surgimend in acellular dermal matrix¿assisted, implant-based immediate breast reconstruction. " the aim of this study was to compare strattice and surgimend for postoperative clinical outcomes following immediate, implant-based breast reconstruction. Methods: the study, conducted across three hospitals, included all patients who underwent immediate implant-based breast reconstruction using strattice and surgimend. The primary outcome measure was implant loss rate. Secondary outcome measures included acellular dermal matrix loss rate, seroma formation, and minor and major complication rates. Intergroup comparison was performed. Strattice (porcine derivative) and surgimend (bovine derivative) are the two most common acellular dermal matrices used in breast reconstruction in the united kingdom. This retrospective study compared clinical outcomes in immediate implant-based breast reconstruction patients. Eighty-two patients (strattice, n
=
45; surgimend, n
=
37) underwent 97 immediate implant-based breast reconstructions (strattice, n
=
54; surgimend, n
=
43). Postoperative outcomes for surgimend: implants loss within 3 months - 3 (wound breakdown 1; infection 2). Local complications: postoperative complication - 21, seroma - 20 - (5 seromas drained), hematoma - 5, skin flap problems - 10, nipple-areola problems - 5, red breast - 9, other minor complications - 3. Infections outcomes: implant infection - 2, wound infection - 9, therapeutic antibiotics - 12, reoperation - 3 - reason for reoperation: removal of implant and washout (2); removal of implant, washout and insertion of expander (1). Results: there were no differences between groups for age, comorbidities, specimen weight, or implant volume. Drains were used in all strattice and 36 (84 percent) surgimend cases. The implant loss rate was higher for strattice compared with surgimend, but failed to reach statistical significance. The acellular dermal matrix loss rate was significantly higher in the strattice group, with no acellular dermal matrix loss with surgimend. The reoperation rate was also significantly higher in the strattice group. The incidence of red breast was significantly higher in the surgimend group. Seroma, wound problems, and infection rates were similar. Conclusions: clinical outcomes, including implant loss, acellular dermal matrix loss, and reoperation rates, are significantly better when using surgimend in immediate implant-based breast reconstruction compared with strattice.
 
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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
sonia irizarry
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8212303
MDR Text Key131916487
Report Number3004170064-2019-00001
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K083898
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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