N
Patient 0
A REVIEW OF THE SURGICAL GUIDE CASE INDICATE TAHT IT WAS AN ERROR DURING THE GUIDE'S SLEEVING PROCESS.
MAUDE MDR 25111332
- MDR report key
- 25111332
- Report number
- 3011429437-2026-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-02-25
- Date received
- 2026-05-07
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 1
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- MR EHAB AMIN
- Address
- 24 DENBY RD SUITE 148 ALLSTON MA 02134 US
- Phone
- 866-866-8668
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 58085 | 3DDX DENTAL SURGICAL GUIDE | DENTAL IMPLANT SURGICAL GUIDE | 3D DIAGNOSTIX INC. | NDP | 631719 | N | N | |||||
| 347619 | 3DDX DENTAL SURGICAL GUIDE | DENTAL IMPLANT SURGICAL GUIDE | 3D DIAGNOSTIX INC. | NDP | 631719 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-05-07 | 0 |
Event Narratives#
D
Patient 0
DOCTOR MENTIONED THAT THE GUIDE DID NOT STOP HER FOR THE PILOT SITE AND WENT WAY DEEPER THAN PLANNED.