FDA Adverse Event
Injury
Summary report: N
IMPLANT: HA, 13MM, INTEGRAL, 3.25
MDR report key: 130677
·
Received November 11, 1997
Report
- Report Number
- 2023141-1997-00886
- Event Type
- Injury
- Date Received
- November 11, 1997
- Date of Event
- January 7, 1997
- Report Date
- October 13, 1997
- Manufacturer
- SULZER CALCITEK
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR'S OFFICE.
Description of Event or Problem · 1
DR. REPORTED THAT AN IMPLANT FALLED DUE TO INFECTION. PT IS SAME PT AS MEDWATCH REPORTS #2023141-1997-00885. 2023141-1997-00887 AND 2023141-1997-00888.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANT: HA, 13MM, INTEGRAL, 3.25 Implant | HA CYLINDER ENDOSSEOUS DENTAL IMPLANT | DZE | SULZER CALCITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |