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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VERITAS MESH, SURGICAL

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SYNOVIS SURGICAL INNOVATIONS VERITAS MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seroma (2069)
Event Date 11/12/2015
Event Type  Injury  
Manufacturer Narrative
(b)(6). This report was received from a physician and referenced literature article from the european journal of plastic surgery/10. 1007/s00238-017-1389-5 titled: complete resorption of veritas in acellular dermal matrix (adm)-assisted implant -bases breast reconstructions-is there a need for tighter regulation of new products developed for use in breast reconstruction?, fayyaz a. K. Mazari;, kristjan s. Asgeirsson, lisa whisker, eleanor gutteridge, tuabin rasheed, r. Dourglas macmillan. The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A patient experienced complete resorption of veritas which caused a seroma, after undergoing a surgery in which veritas was used. The resorption was further described as ¿bottoming out of the implant¿ which required revision surgery. The patient had undergone breast reconstruction surgery. The implants were placed partially under the pectoralis major muscle with veritas used to cover the lower pole of the implant and sutured to the pectoralis major muscle superiorly to hold the detached end of the muscle in position and to the chest wall inferiorly and laterally. Subsequently, the surgeon noted that there was no veritas and/or no integration of lower pole, the veritas collagen matrix was dissolved leaving only a yellow, gel-like seroma in the implant cavity. The veritas dissolved over an 18 month period. This required the patient to undergo revision surgery (date unspecified). No further detail was provided regarding the patient¿s outcome from the event. No additional information is available.
 
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Brand NameVERITAS
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SYNOVIS SURGICAL INNOVATIONS
saint paul MN
Manufacturer (Section G)
SYNOVIS SURGICAL INNOVATIONS
2575 university ave w
saint paul MN 55114
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7432721
MDR Text Key105558433
Report Number1416980-2018-02160
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/21/2018
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

Patient Treatment Data
Date Received: 04/16/2018 Patient Sequence Number: 1
Treatment
MONOFILAMENT SUTURES (2-0)
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