MAUDE Adverse Event Report: B.T.I. BIOTECHNOLOGY INSTITUTE S.L.; Implant, endosseous, root-form

Model Number	IRTCA3713
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician indicates that the screw fractured inside the implant.An attempt was made to remove it and, during this process, the implant connection was damaged.Consequently, the clinician removed the implant.No complications were reported during or after the operation for the patient.
Additional Manufacturer Narrative
The batch documentation is checked and no anomalies are detected.Any manufacturing fault is ruled out.After examination of the implant, it can be verified that the implant does not show signs of misuse or signs of malfunction that could have contributed to the event.However, the method used for screw recovery was not the one recommended by the manufacturer.

• Common Device Name: Implant, endosseous, root-form
• Manufacturer (Section D): B.T.I. BIOTECHNOLOGY INSTITUTE S.L.; leonardo da vinci street, 14; minano menor, alava 01510 ; SP 01510
• Manufacturer (Section G): B.T.I. BIOTECHNOLOGY INSTITUTE S.L.; leonardo da vinci street, 14; minano menor, alava 01510 ; SP 01510
• Manufacturer Contact: jose rivero ; leonardo da vinci street, 14; minano menor, alava 01510 ; SP 01510
• MDR Report Key: 21123021
• Report Number: 3004417597-2024-00223
• Device Sequence Number: 18326052
• Product Code: DZE
• UDI-Device Identifier: 08435389815051
• UDI-Public: 08435389815051
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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 Expiration Date: 03/31/2023
• Device Model Number: IRTCA3713
• Device Lot Number: AH00660.Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male