FDA Adverse Event
Injury
Summary report: N
INTERNA NARROW PLATFORM IMPLANT CA
MDR report key: 19817700
·
Received July 24, 2024
Report
- Report Number
- 3004417597-2024-00040
- Event Type
- Injury
- Date Received
- July 24, 2024
- Date of Event
- February 21, 2024
- Manufacturer
- B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
- Product Code
- DZE
- PMA / PMN Number
- K211952
- 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. HOWEVER, IT IS FOUND THAT THE DRILLING PROTOCOL USED IS DIFFERENT FROM THE RECOMMENDED ONE.
Description of Event or Problem · 0
THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2024 AND A MONTH AND A HALF LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY II. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350575 | INTERNA NARROW PLATFORM IMPLANT CA | DZE | B.T.I. BIOTECHNOLOGY INSTITUTE S.L. | IIPECA3575 | BC04346.A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention |