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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX SXPD2B202 20S-8 #2 PDO 36 X 36

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SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX SXPD2B202 20S-8 #2 PDO 36 X 36 Back to Search Results
Model Number SXPD2B202
Device Problem Insufficient Information (3190)
Patient Problem Wound Dehiscence (1154)
Event Type  Injury  
Manufacturer Narrative
Method-the actual devices were not received for review. Samples from the reported lot were not returned for testing/review. A sample that was retained with the device history record was reviewed. Results/conclusion-a retained sample from the same lot was reviewed and photographed. The sample was barbed and met all current requirements for this size/type barbed suture device. Relevant portions of the device history record were reviewed. The finished good devices and all components met current usp and ssm requirements throughout the incoming inspection, manufacturing and final inspection processes. No inventory is available of the reported finished good lot. The retained sample was barbed per current requirements. Without receiving detailed information regarding the procedure, suture placement, technique utilized by the surgeon, patient specific health status, post-operative instructions or events a definitive root cause for the reported dehiscence cannot be confirmed at this time.
 
Event Description
It was reported that during an unknown orthopedic procedure the surgeon noted little to no barbs on two (2) of the sxpd2b202 devices. The device was utilized and the fascia layer was closed without incident. However, later (post-operatively) the surgeon learned of a wound dehiscence. No additional details regarding the patient''s health status or other patient specific information was obtained. Detailed information regarding the surgeon''s technique, post-operative events that may have induced the dehiscence or type of medical intervention provided were not disclosed.
 
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Brand NameSTRATAFIX
Type of DeviceSTRATAFIX SXPD2B202 20S-8 #2 PDO 36 X 36
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key7292467
MDR Text Key100800009
Report Number3010692967-2018-00004
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
PMA/PMN Number
K120827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Model NumberSXPD2B202
Device Catalogue NumberSXPD2B202
Device Lot NumberAABQ517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/24/2018
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer01/29/2018
Date Manufacturer Received01/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/23/2018 Patient Sequence Number: 1
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