MAUDE Adverse Event Report: COLTENE WHALEDENT INC. ALPEN; BUR

Catalog Number R5001/4

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The 1/4 surgical lengths snapping right off, stuck in patient's gum/bone.

• Brand Name: ALPEN
• Type of Device: BUR
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7874204
• MDR Text Key: 120576264
• Report Number: 2416455-2018-09132
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R5001/4
• Device Lot Number: I17189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1