MAUDE Adverse Event Report: ALTATEC GMBH CAMLOG SCREW LINE IMPLANT

Model Number K1045.3811

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Dental implant could not be placed because he used old instruments.

Event Description

Dental implant could not be placed because he used old (incompatible) instruments.

• Brand Name: CAMLOG SCREW LINE IMPLANT
• Type of Device: CAMLOG SCREW 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: 12473365
• MDR Text Key: 271434843
• Report Number: 9613866-2021-59328
• 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: 09/15/2021

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: K1045.3811
• Device Catalogue Number: K1045.3811
• Device Lot Number: 0010105676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/15/2021
• 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: 35 YR