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

Model Number HC465 4.5MM , 6.5MM X 5MM

Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2020

Event Type  Injury  

Event Description

A zimmer dental implant failed.Pieces of the implant/collar broke off and were lodged in the bone, causing mobility of the implant and extensive bone loss and tissue granulation which had to be debrided.Fda safety report id # (b)(4).

• Brand Name: ZIMMER DENTAL IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): ZIMMER DENTAL INC.
• MDR Report Key: 11131748
• MDR Text Key: 226050891
• Report Number: MW5098717
• Device Sequence Number: 1
• Product Code: DZE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2021

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
• Device Operator: No Information
• Device Model Number: HC465 4.5MM , 6.5MM X 5MM
• Device Lot Number: 62452480
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 75