MAUDE Adverse Event Report: ALTATEC GMBH CAMLOG PROGRESSIVE LINE IMPLANT

Model Number K1075.4311

Device Problem Packaging Problem (3007)

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

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

User claims that sterile barrier was damaged.Ifu clearly prohibits product usage if sterile barrier is damaged.It is incomprehensible why dentist used the products and removed the implant after implantation.Packaging was approved and within validated specifications for sealing.User should have consulted ifu prior to use the product.

Event Description

Sterile barrier damaged.Product was opened and used even if ifu prohibit usage if sterile barrier is damaged.

• 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: 14913302
• MDR Text Key: 295219044
• Report Number: 9613866-2022-72679
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K1075.4311
• Device Catalogue Number: K1075.4311
• Device Lot Number: 0000093058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• 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: 39 YR
• Patient Sex: Male