MAUDE Adverse Event Report: HAGER & MEISINGER GMBH IMPLANT OKTAGON TL RP 4.1X10MM; DENTAL IMPLANT

Model Number 3631152DU0ACE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.

Event Description

Handling mistake.

• Brand Name: IMPLANT OKTAGON TL RP 4.1X10MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• Manufacturer (Section G): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• Manufacturer Contact: eva schaffert ; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• MDR Report Key: 14874425
• MDR Text Key: 295404853
• Report Number: 8010516-2022-00075
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: E0HM311521
• UDI-Public: +E0HM311521/$B94821/14D20251031/Q1G
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K122807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/30/2022

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: 3631152DU0ACE
• Device Catalogue Number: 31152
• Device Lot Number: B94821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female