MAUDE Adverse Event Report: COLTENE WHALEDENT INC. PARAPOST TAPERLUX INTRO KIT; FIBER POST KIT

Catalog Number	PF180
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not respond to numerous requests for more information.To be conservative, this complaint is being evaluated as an adverse event.All communications occurred through the dealer/distributor.
Event or Problem Description
Faulty product.Blue drill, bent first time used.Using to drill root for cast post to be made in the lab.

• Brand Name: PARAPOST TAPERLUX INTRO KIT
• Common Device Name: FIBER POST KIT
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 9527243
• Report Number: 2416455-2019-00005
• Device Sequence Number: 11436838
• Product Code: ELR
• UDI-Device Identifier: D661PF1801
• UDI-Public: D661PF1801
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PF180
• Device Lot Number: I38450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other