MAUDE Adverse Event Report: ALTATEC GMBH CAMLOG SCREW LINE IMPLANT PROMOTE PLUS

Model Number K1056.4309

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

Healing cap could not be loosened from dental implant and implant was turned out during procedure.During product evaluation the healing cap could be removed from the implant.There were residues from blood and bone between the implant and healing cap connection.This should not happen and is caused by inadequate procedure by the dentist.

Event Description

Healing cap could not be loosened from dental implant and implant was turned out during procedure.

• Brand Name: CAMLOG SCREW LINE IMPLANT PROMOTE PLUS
• Type of Device: CAMLOG SCREW LINE 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: 13448245
• MDR Text Key: 285033368
• Report Number: 9613866-2022-65863
• 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: 04/02/2022

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: K1056.4309
• Device Catalogue Number: K1056.4309
• Device Lot Number: 0000106441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/04/2022
• 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: 70 YR
• Patient Sex: Male