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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALITIES STRATAFIX STRATAFIX PDO

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SURGICAL SPECIALITIES STRATAFIX STRATAFIX PDO Back to Search Results
Model Number SXPD2B412
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Irritation (2076); Reaction (2414)
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 have not been provided which precludes a dhr review from being performed at this time including sterility records. Unfortunately without the lot information we are unable to determine a root cause at this time. Should the device be returned to surgical specialties corporation at some point in the future the issue will be re-opened, the device evaluated and the findings from the evaluation will be documented in the complaint file and a follow-up report will be filed at that time. 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 by the distributor/sales rep that a patient presented with skin irritations and suture spitting. An email was received by the distributor that a skin graft may be required to repair infected or damaged tissue; however, to date no additional information has been forthcoming regarding whether surgical intervention was performed. 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.
 
Manufacturer Narrative
Corrected the site state abbreviation to (b)(6) from (b)(6).
 
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Brand NameSTRATAFIX
Type of DeviceSTRATAFIX PDO
Manufacturer (Section D)
SURGICAL SPECIALITIES
rd 459 montana industrial park
aquadilla PR 00605
MDR Report Key8184345
MDR Text Key131007783
Report Number3010692967-2018-00029
Device Sequence Number1
Product Code GAB
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 01/01/2005,12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSXPD2B412
Was Device Available for Evaluation? No
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 Received01/14/2005
Is This a Reprocessed and Reused Single-Use Device? Yes

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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