• 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 SXPD2B405
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Fluid Discharge (2686)
Event Date 08/16/2018
Event Type  Injury  
Manufacturer Narrative
To date the samples have not been received by surgical specialties corporation for root cause and failure analysis. Without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the reports of infection/skin reactions, results of the culture or blood screen to identify the type of infection/reaction and antibiotics prescribed, a definitive root cause cannot be determined at this time.
 
Event Description
Post-operation infection. The patient is female and (b)(6). She had ingle-segmental lumbar disc herniation operation on (b)(6) 2018. The suture was used to sew muscle. However, in (b)(6) 2018, the patient complained that the yellow fluid came out from wound which was red and swollen. The surgeon removed the sxpd2b405 and changed vcp358h to re-sew the wound, now the patient is being restored. Representative samples will be returned for evaluation.
 
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 PR 19608
Manufacturer Contact
ronald giannangelo
247 station drive
suite ne1
westwood, MA 02090
MDR Report Key7877803
MDR Text Key120379664
Report Number3010692967-2018-00022
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 consumer,literature,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/01/2005,06/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Model NumberSXPD2B405
Device Catalogue NumberSXPD2B405
Device Lot NumberMDWA120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-