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

Model Number K1056.4311

Device Problems Fracture (1260); Device-Device Incompatibility (2919)

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

Event Date 05/22/2023

Event Type  Injury  

Event Description

Implant fracture in combination with prosthetic component from a 3rd party manufacturer (not from original system).

Manufacturer Narrative

Implant fracture in combination with prosthetic component from a 3rd party manufacturer (not from original system).Dentist used prosthetic from a different system.The ifu clearly states that only original prosthetic components shall be used to assure safe and reliable results fracture was caused by the combination of products from different systems by user.

• 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, bw 71299 ; GM 71299
• Manufacturer (Section G): ALTATEC GMBH; maybachstr. 5; wimsheim, bw 71299 ; GM 71299
• Manufacturer Contact: raphael brausch ; maybachstr. 5; wimsheim, bw 71299 ; GM 71299
• MDR Report Key: 18533043
• MDR Text Key: 333085503
• Report Number: 9613866-2024-01532
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K1056.4311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• 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: 68 YR
• Patient Sex: Female