FDA Adverse Event
Injury
Summary report: N
INTERNA UNIVERSAL PLUS PLATFORM IMPLANT CA
MDR report key: 19792813
·
Received July 22, 2024
Report
- Report Number
- 3004417597-2024-00035
- Event Type
- Injury
- Date Received
- July 22, 2024
- Manufacturer
- B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
- Product Code
- DZE
- UDI-DI
- 08435389811893
- PMA / PMN Number
- K151391
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
THE CLINICIAN INDICATES THAT HE DETECTS THAT THE IMPLANT HAS NOT OSSEOINTEGRATED. PATIENT WITH A BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2075480 | INTERNA UNIVERSAL PLUS PLATFORM IMPLANT CA | DZE | B.T.I. BIOTECHNOLOGY INSTITUTE S.L. | IIPSCA5065 | BO03140.Z | 08435389811893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |