MAUDE Adverse Event Report: ALTATEC GMBH CONELOG SL IMPLANT PROMOTE PLUS

Model Number C1064.4311

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Healing cap was too tight on the dental implant and could not be removed.Implant needed to be explanted.Dentist did not clean the inner thread of the implant prior to attach the healing cap.Dentist should have consulate ifu.

Event Description

Healing cap was too tight on the dental implant and could not be removed.Implant needed to be explanted.

• Brand Name: CONELOG SL IMPLANT PROMOTE PLUS
• Type of Device: CONELOG SL IMPLANT PROMOTE PLUS
• Manufacturer (Section D): ALTATEC GMBH; maybachstr. 5; wimsheim, 71299 ; GM 71299
• Manufacturer (Section G): ALTATEC GMBH; maybachstr. 5; wimsheim, 71299 ; GM 71299
• Manufacturer Contact: raphael brausch ; maybachstr. 5; wimsheim, 71299 ; GM 71299
• MDR Report Key: 12524155
• MDR Text Key: 273064061
• Report Number: 9613866-2021-58225
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/24/2021

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: C1064.4311
• Device Catalogue Number: C1064.4311
• Device Lot Number: 0020108556
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 67 YR