FDA Adverse Event
Malfunction
Summary report: N
SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU
MDR report key: 10971205
·
Received December 8, 2020
Report
- Report Number
- 0002023141-2020-02247
- Event Type
- Malfunction
- Date Received
- December 8, 2020
- Report Date
- December 22, 2020
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K011028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION FROM THE CUSTOMER THAT REVEALS THAT THE SCREW WAS STUCK IN THE ABUTMENT, NOT THE IMPLANT. THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS. NO FURTHER MEDWATCH REPORTS WILL BE SUBMITTED FOR THIS EVENT.
Description of Event or Problem · 0
ADDITIONAL INFORMATION FROM THE CUSTOMER REVEALS THAT THE SCTS SCREW WAS STUCK IN THE ABUTMENT, NOT IN THE IMPLANT.
Additional Manufacturer Narrative · 1
ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510(K) NUMBER IS K011038.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SCTS SCREW GOT STUCK IN THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1435178 | SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU | SCREW | DZE | ZIMMER DENTAL | 2019080767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |