FDA Adverse Event
Injury
Summary report: N
ALTATEC
MDR report key: 19473059
·
Received June 5, 2024
Report
- Report Number
- 1060818-2024-60418
- Event Type
- Injury
- Date Received
- June 5, 2024
- Date of Event
- April 9, 2024
- Report Date
- May 9, 2024
- Manufacturer
- ALTATEC
- Product Code
- DZE
- UDI-DI
- E219K105650091
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IT
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE NEW SYSTEM REVEALED THIS RECORD WAS NOT SUBMITTED. THE SYSTEM HAS BEEN PROVIDING ERRORS DURING SUBMISSION. CORRECTION ACTION ¿ SUBMITTED RECORD ON DAY OF DISCOVERY. ALERT VENDOR OF ANY ERRORS RECEIVED DURING THE SUBMISSION OF THE RECORD FOR FURTHER RESEARCH AND INVESTIGATION. PREVENTATIVE ACTION ¿ RUN REPORT TO ENSURE RECORDS HAVE BEEN TRANSMITTED BY THEIR RESPECTIVE DUE DATE.
Description of Event or Problem · 0
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6902 | ALTATEC | DENTAL IMPLANT | DZE | ALTATEC | K1056.5009 | 0010117302 | E219K105650091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |