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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGENTEC, LLC FACETCORE SYSTEM; FACETCORE LOCATOR
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SURGENTEC, LLC FACETCORE SYSTEM; FACETCORE LOCATOR Back to Search Results
Lot Number SM114620
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/19/2021
Event Type  malfunction  
Event Description
The physician was doing an open case, while targeting with the facet locator by visualization, the impactor was placed over the facet locator and malleted to help drive the facet locator into the proper position.The drill guide was the placed over the face locator.When the physician tried to remove the face locator, it would not come out, it took some time and force to remove the facet locator from its' position and when removed, one of the distal tines of the facet locator was no longer attached.Upon further inspection and imaging the tine was lodged in the bone of the facet joint and could not be removed.Surgery was completed without further complication and facet locator issue did not add much time to overall surgery.
 
Event Description
The physician was doing an open case, while targeting with the facet locator by visualization, the impactor was placed over the facet locator and malleted to help drive the facet locator into the proper position.The drill guide was the placed over the face locator.When the physician tried to remove the face locator, it would not come out, it took some time and force to remove the facet locator from its' position and when removed, one of the distal tines of the facet locator was no longer attached.Upon further inspection and imaging the tine was lodged in the bone of the facet joint and could not be removed.Surgery was completed without further complication and facet locator issue did not add much time to overall surgery.
 
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Brand Name
FACETCORE SYSTEM
Type of Device
FACETCORE 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
andrew shoup
911 clint moore rd
boca raton, FL 33487
5619907882
MDR Report Key12778288
MDR Text Key285162167
Report Number3012495575-2021-00002
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberSM114620
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/19/2021
Initial Date FDA Received11/09/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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