MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT

Model Number	P1110.3811
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.

• Brand Name: ALTATEC
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ALTATEC; maybachstrause; wimsheim ; GM
• MDR Report Key: 19015336
• Report Number: 1060818-2024-60187
• Device Sequence Number: 3880769
• Product Code: DZE
• UDI-Device Identifier: E219P111038111
• UDI-Public: E219P111038111
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/11/2024

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: P1110.3811
• Device Catalogue Number: P1110.3811
• Device Lot Number: 0060135845
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown