MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT

Model Number	C2432.5013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Connection fracture.

• Brand Name: ALTATEC
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ALTATEC; maybachstrasse 5; wimsheim 71299 ; GM 71299
• MDR Report Key: 20245821
• Report Number: 1060818-2024-60778
• Device Sequence Number: 7301160
• Product Code: DZE
• UDI-Device Identifier: E219C243250131
• UDI-Public: E219C243250131
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/21/2024

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
• Operator of Device: Health Professional
• Device Model Number: C2432.5013
• Device Catalogue Number: C2432.5013
• Device Lot Number: 0000141687
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown