FDA Adverse Event
Malfunction
Summary report: N
TI TITAMAX IMPLANT (5.0) 5.0X9
MDR report key: 5014878
·
Received August 5, 2015
Report
- Report Number
- 3010593814-2015-01854
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Date of Event
- January 8, 2015
- Report Date
- June 26, 2015
- Manufacturer
- NEODENT
- Product Code
- DZE
- PMA / PMN Number
- K101207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
THE DENTIST REPORTED THE REMOVAL OF A DENTAL IMPLANT DURING INSTALLATION SURGERY DUE TO ITS' LACK OF PRIMARY STABILITY. PATIENT PRESENTED BONE TYPE IV.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517776 | TI TITAMAX IMPLANT (5.0) 5.0X9 | DZE | NEODENT | NA | 800108288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |