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

Model Number	IIPUCA3585
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2020
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.The product could not be reviewed as it has not been shipped.
Event or Problem Description
The clinician indicates that he placed the implant on (b)(6) 2019 and one month later it was noted that the implant had not osseointegrated.Patient with bone quality ii.In the event the patient experienced: infection and discomfort.

• Common Device Name: INTERNA UNIVERSAL PLATFORM IMPLANT
• 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: 19665725
• Report Number: 3004417597-2024-00006
• Device Sequence Number: 6549559
• Product Code: DZE
• UDI-Device Identifier: 08435389812104
• UDI-Public: 08435389812104
• 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: 2020
• 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: 05/01/2024
• Device Model Number: IIPUCA3585
• Device Lot Number: AI02308.Z
• Was Device Available for Evaluation?: No
• 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): No
• Date Device Manufactured: 05/30/2019
• 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: 74 YR
• Patient Sex: Female