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

Model Number	K1054.5009
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration (dental implant).

• Brand Name: CAMLOG SCREW-LINE IMPLANT PROMOTE-PLUS
• Common Device Name: CAMLOG SCREW-LINE IMPLANT PROMOTE-PLUS
• Manufacturer (Section D): ALTATEC GMBH; maybachstrasse.5; wimsheim, ; GM
• Manufacturer (Section G): ALTATEC GMBH; maybachstrasse.5; wimsheim, 71299 ; GM 71299
• Manufacturer Contact: monika hentschel ; maybachstrasse 5; wimsheim, 71299 ; GM 71299
• MDR Report Key: 24738490
• Report Number: 9613866-2026-50428
• Device Sequence Number: 9864612
• Product Code: DZE
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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
• Operator of Device: Health Professional
• Device Model Number: K1054.5009
• Device Lot Number: 0010093321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male