MAUDE Adverse Event Report: B.T.I. BIOTECHNOLOGY INSTITUTE S.L.; EXTERNA UNIVERSAL PLATFORM IMPLANT CA

Model Number	IRPUCA4010
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
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, there is a small gap between the implant and the cover screw, as well as signs of infection around this area.
Event or Problem Description
The clinician indicates that he placed the implant on (b)(6) 2019 and four-months later it was noted that the implant had not osseointegrated.Patient with bone quality ii.In the event the patient experienced: infection.

• Common Device Name: EXTERNA UNIVERSAL PLATFORM IMPLANT CA
• 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: 19665782
• Report Number: 3004417597-2024-00007
• Device Sequence Number: 12474752
• Product Code: DZE
• UDI-Device Identifier: 08435389815204
• UDI-Public: 08435389815204
• 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: 2019
• 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: 04/01/2024
• Device Model Number: IRPUCA4010
• Device Lot Number: AI01695.Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2019
• 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: 69 YR
• Patient Sex: Male