FDA Adverse Event
Injury
Summary report: N
ANATOMAGE INC.
MDR report key: 7664706
·
Received July 5, 2018
Report
- Report Number
- 3008272529-2018-00022
- Event Type
- Injury
- Date Received
- July 5, 2018
- Date of Event
- May 10, 2018
- Report Date
- May 29, 2018
- Manufacturer
- ANATOMAGE INC.
- Product Code
- NDP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD DID NOT SHOW ANY PRODUCTION ERROR. ISSUE AT SITE #9 LIKELY CAUSED BY IMMEDIATE EXTRACTION.
Description of Event or Problem · 1
DOCTOR USED A SURGICAL GUIDE TO PLACE DENTAL IMPLANT. BASED ON POST OP SCAN HE SAID THE IMPLANTS 8 AND 9 WERE TOO BUCCAL. IMPLANT #9 FELL OUT AND DID NOT GRAB ANY BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 507411 | ANATOMAGE INC. | SURGICAL GUIDE | NDP | ANATOMAGE INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |