FDA Adverse Event
Malfunction
Summary report: N
STERI-OSS DENTAL IMPLANT
MDR report key: 118033
·
Received September 2, 1997
Report
- Report Number
- 2027763-1997-01098
- Event Type
- Malfunction
- Date Received
- September 2, 1997
- Date of Event
- August 12, 1997
- Report Date
- September 2, 1997
- Manufacturer
- STERI-OSS, INC.
- Product Code
- DZE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
RECEIVED REPORT OF A FAILURE. NO FURTHER INFO AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERI-OSS DENTAL IMPLANT Implant | ENDOSSEOUS DENTAL IMPLANT | DZE | STERI-OSS, INC. | 3414HL | 971943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |