• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES PUERTO RICO, INC. STRATAFIX STRATAFIX SPIRAL PDO

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SURGICAL SPECIALTIES PUERTO RICO, INC. STRATAFIX STRATAFIX SPIRAL PDO Back to Search Results
Model Number SXPD2B412
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Skin Irritation (2076)
Event Date 11/12/2018
Event Type  Injury  
Manufacturer Narrative
To date, the complaint device has not been returned to surgical specialties corporation for root cause analysis. The lot number has not been provided which precludes a dhr review from being performed at this time. Unfortunately without the device or lot information we are unable to determine a root cause at this time. Should the device be returned or additional information received about the events, surgical specialties corporation the file will be re-opened. Pdo (polidioxanone) material is essentially absorbed between 182 and 238 days post implantation. However, this specific material has in vivo strength retention for up to six (6) weeks. All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject. Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months. Still in some cases, the body decides not to break them down but instead pushes them out through the top of the skin. That is why it is not uncommon for spitting sutures to occur. Spitting of suture material can also be the result of placing the material too superficially. The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event. Without receiving detailed information regarding the procedure, technique and post-operative details, a definitive root cause cannot be determined at this time.
 
Event Description
It was reported to the sales rep that nine patients in the last month have experienced skin irritations and suture spitting. Today the customer emailed the sales rep to inform the sales rep of this and they were headed to the or and most likely will have to did a skin graft on this patient. The pa and doctor believe it has to due with the stratafix suture since they have not changed anything with technique or products in the last years.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRATAFIX
Type of DeviceSTRATAFIX SPIRAL PDO
Manufacturer (Section D)
SURGICAL SPECIALTIES PUERTO RICO, INC.
rd.459 montana industrial park
aquadila 00605
Manufacturer Contact
ronald giannangelo
247 station drive
suite ne1
westwood, MA 02090
MDR Report Key8128908
MDR Text Key129192647
Report Number3010692967-2018-00028
Device Sequence Number1
Product Code GAB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSXPD2B412
Device Catalogue NumberSXPD2B412
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Distributor Facility Aware Date11/12/2018
Event Location Hospital
Date Report to Manufacturer01/10/2005
Date Manufacturer Received11/21/2018
Is This a Reprocessed and Reused Single-Use Device? Yes

-
-