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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. EXTR. FCPS, GRIP DEEP 150; M51 - GENERAL DENTISTRY
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INTEGRA YORK, PA INC. EXTR. FCPS, GRIP DEEP 150; M51 - GENERAL DENTISTRY Back to Search Results
Catalog Number DEFDG150
Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)
Patient Problem Tooth Fracture (2428)
Event Date 06/02/2014
Event Type  malfunction  
Event Description
Customer initially reports device not working properly.On (b)(6) 2014 doctor reports device is not gripping parallel, and is sliding around tooth where it is supposed to grip a root.Tooth broke off causing doctor the need to cut the tooth to remove it, extending the procedure beyond the norm.No harm to patient.Event took place in (b)(6), no detail available about age or gender of the patient.
 
Manufacturer Narrative
To date the device involved in the reported incident has not been rec'd for evaluation.An investigation has been initiated based on the reported info.
 
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Brand Name
EXTR. FCPS, GRIP DEEP 150
Type of Device
M51 - GENERAL DENTISTRY
Manufacturer (Section D)
INTEGRA YORK, PA INC.
york PA 17402
Manufacturer Contact
sandra lee
315 enterprise drive
6099366828
MDR Report Key4030845
MDR Text Key4844238
Report Number2523190-2014-00053
Device Sequence Number1
Product Code EMG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDEFDG150
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/24/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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