MAUDE Adverse Event Report: DENTAL IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 34124

Device Problem Break (1069)

Patient Problems Sensitivity of Teeth (2427); Implant Pain (4561)

Event Type  Injury  

Event Description

Report of adverse event info about a device that was not manufactured or imported by the straumann group.Implant broke.Pain, increased sensitivity.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DENTAL IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• MDR Report Key: 17288085
• MDR Text Key: 318717691
• Report Number: MW5119223
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 34124
• Device Lot Number: 13065396
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male