FDA Adverse Event
Injury
Summary report: N
INTERPORE IMZ IMPLANT
MDR report key: 83356
·
Received April 9, 1997
Report
- Report Number
- 2029012-1997-00081
- Event Type
- Injury
- Date Received
- April 9, 1997
- Date of Event
- February 25, 1997
- Report Date
- April 9, 1997
- Manufacturer
- INTERPORE INTL.
- Product Code
- DZE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DENTAL IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATIONL. THE PT DEVELOPED EXUDATE 2-3 MONTHS POST-IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERPORE IMZ IMPLANT Implant | ENDOSSEOUS DENTAL IMPLANT | DZE | INTERPORE INTL. | NA | 608001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |