FDA Adverse Event
Injury
Summary report: N
IMPLANT: HA, 10MM,INTEGRAL, 4.0
MDR report key: 42672
·
Received October 11, 1996
Report
- Report Number
- 2023141-1996-00120
- Event Type
- Injury
- Date Received
- October 11, 1996
- Date of Event
- September 11, 1996
- Report Date
- September 12, 1996
- Manufacturer
- 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 NOT AVAILABLE FROM THE DOCTOR'S OFFICE.
Description of Event or Problem · 1
A PT PRESENTED WITH MOBILE IMPLANT, PAIN, AND EXUDATE, TOOTH AREA #3, TWO UNIT IMPLANT SUPPORTED BRIDGE. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023111-1996-121.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANT: HA, 10MM,INTEGRAL, 4.0 Implant | HA CYLINDER ENDOSSEOUES DENTAL IMPLANT | DZE | CALCITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |