MAUDE Adverse Event Report: COLTENE WHALEDENT INC. PARAPOST

Catalog Number	P6850
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Post broke in patient's mouth.Dr is looking for explanation as he has never had this happen before.
Additional Manufacturer Narrative
Attachment: [device evaluation 2416455-2018-00012.Xml].

• Brand Name: PARAPOST
• Common Device Name: POST
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7996005
• Report Number: 2416455-2018-00012
• Device Sequence Number: 1387024
• Product Code: ELR
• UDI-Device Identifier: D661P68501
• UDI-Public: D661P68501
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: P6850
• Device Lot Number: 19596
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1