MAUDE Adverse Event Report: INTEGRA YORK, PA INC 301 ELEV; M51 - GENERAL DENTISTRY

Catalog Number DEL301

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

Customer initially reports broken tip.(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.

• 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 Key: 3964284
• MDR Text Key: 4562077
• Report Number: 2523190-2014-00038
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DEL301
• Device Lot Number: GD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• Date Device Manufactured: 07/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 21 YR