MAUDE Adverse Event Report: ALTATEC GMBH CAMLOG PROGRESSIVE LINE IMPLANT

Model Number K1076.3813

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/13/2022

Event Type  Injury  

Event Description

Implant could not be placed to the final position and needed to be removed.Another implant was placed in another position during the same session.Dentist should have used dense bone drill or tap in hard bone.

• Brand Name: CAMLOG PROGRESSIVE LINE IMPLANT
• Type of Device: CAMLOG PROGRESSIVE LINE IMPLANT
• 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: 13391355
• MDR Text Key: 284674218
• Report Number: 9613866-2022-65557
• 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: 01/31/2022

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: K1076.3813
• Device Catalogue Number: K1076.3813
• Device Lot Number: 0010111310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male