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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGENTEC, LLC FACETCORE SYSTEM; FACET LOCATOR
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SURGENTEC, LLC FACETCORE SYSTEM; FACET LOCATOR Back to Search Results
Lot Number SM114620
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 11/10/2020
Event Type  malfunction  
Event Description
One of two distal prongs of the facet locator appeared to have been broken off because the existing rod & screw construct hindered the deployment of the instrument.In doing so, one of the prongs may have gotten caught up on the screw, set screw, and rod interface causing it to break off upon impaction.It is believed the prong is lodged next to the existing construct as it could not be found with imaging.As per the representative the surgeon was using excessive force malleting the facet locator against an existing construct witch led to the instrument failure.
 
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Brand Name
FACETCORE SYSTEM
Type of Device
FACET LOCATOR
Manufacturer (Section D)
SURGENTEC, LLC
911 clint moore rd
boca raton FL 33487
Manufacturer (Section G)
SURGENTEC, LLC
911 clint moore rd
boca raton FL 33487
Manufacturer Contact
stephen inglese
911 clint moore rd
boca raton, FL 33487
5619907882
MDR Report Key10935778
MDR Text Key219549593
Report Number3012495575-2020-00001
Device Sequence Number1
Product Code MDM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberSM114620
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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