FDA Adverse Event
Injury
Summary report: N
IMPLANT, ENDOSSEOUS, ROOT-FORM
MDR report key: 19678197
·
Received July 5, 2024
Report
- Report Number
- 3004417597-2024-00015
- Event Type
- Injury
- Date Received
- July 5, 2024
- Date of Event
- November 5, 2019
- Manufacturer
- B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE BATCH DOCUMENTATION CANNOT BE VERIFIED AS THE AFFECTED BATCH IS NOT PROVIDED. 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 PLACED THE IMPLANT ON (B)(6) 2017 AND, TWO YEARS LATER, IT WAS VERIFIED THAT THE IMPLANT WAS BROKEN. NO COMPLICATIONS WERE REPORTED DURING OR AFTER THE OPERATION FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1282045 | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | B.T.I. BIOTECHNOLOGY INSTITUTE S.L. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention |