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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK PA INC. 301 ELEV; M51 - GENERAL DENTISTRY
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INTEGRA YORK PA INC. 301 ELEV; M51 - GENERAL DENTISTRY Back to Search Results
Catalog Number DEL301
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 02/26/2014
Event Type  malfunction  
Event Description
Customer initially reports broken tips.(b)(6) 2014: dentist reports no harm done.He was doing an extraction when the tip broke off and was retrieved from floor of mouth.Gauze was previously placed as screen protector to prevent swallowing parts.No radiograph taken because fragment matched with the elevator.
 
Manufacturer Narrative
The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.
 
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Brand Name
301 ELEV
Type of Device
M51 - GENERAL DENTISTRY
Manufacturer (Section D)
INTEGRA YORK PA INC.
york PA 17402
Manufacturer Contact
sandra lee
315 enterprise dr.
6099366828
MDR Report Key3960593
MDR Text Key4559308
Report Number2523190-2014-00037
Device Sequence Number1
Product Code DZA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDEL301
Device Lot NumberFX & UNK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/04/2014
Date Device Manufactured06/01/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age30 YR
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