MAUDE Adverse Event Report: ALTATEC ALTATEC DENTAL IMPLANT

Model Number C1085.3311

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2021

Event Type  Injury  

Event Description

Broken implant mount.

• Brand Name: ALTATEC DENTAL IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ALTATEC; maybachstrasse 5; wimsheim, 7122 ; GM 7122
• MDR Report Key: 12110493
• MDR Text Key: 259769653
• Report Number: 1060818-2021-07176
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/14/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: C1085.3311
• Device Catalogue Number: C1085.311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention