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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX SXPD2B405 2 PDO

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SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX SXPD2B405 2 PDO Back to Search Results
Model Number SXPD2B405
Device Problem Insufficient Information (3190)
Patient Problem Wound Dehiscence (1154)
Event Date 03/03/2017
Event Type  Injury  
Manufacturer Narrative
Method-the actual device was discarded by the end user. However, sterile samples from the same finished good lot were returned for review/testing. Results-relevant portions of he device history records were reviewed. The product from the finished good lot and all component lots met current usp and surgical specialties requirements throughout the incoming, manufacturing, in-process and final inspection processes. The returned samples were tested and met the acceptance criteria. Dehiscence is a known risk with and suture material. A definitive root cause for the post-operative dehiscence cannot be determined at this time.
 
Event Description
It was reported by the customer that five patients returned to the same doctor complaining of dehiscence at the suture site after unknown orthopedic procedures. No patient specific information was disclosed. One patient returned less than six weeks with complete dehiscence of the surgical incision.
 
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Brand NameSTRATAFIX
Type of DeviceSTRATAFIX SXPD2B405 2 PDO
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
Manufacturer (Section G)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000 #24702b
ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key6956472
MDR Text Key89565901
Report Number3010692967-2017-00006
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 10/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Model NumberSXPD2B405
Device Catalogue NumberSXPD2B405
Device Lot NumberMBJW300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2016
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: 10/17/2017 Patient Sequence Number: 1
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