FDA Adverse Event
Injury
Summary report: N
SCREW, FIXATION, BONE
MDR report key: 17531839
·
Received August 12, 2023
Report
- Report Number
- MW5138750
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- October 28, 2015
- Manufacturer
- UNKNOWN
- Product Code
- HWC
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE ARTICLE TITLED "ANTERIOR SCREW FIXATION OF TYPE II ODONTOID FRACTURES IN THE ELDERLY" CONSISTS OF ADVERSE EVENTS REGARDING NON-SYNTHES PRODUCT. 142086. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1084659 | SCREW, FIXATION, BONE | SCREW, FIXATION, BONE | HWC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |