FDA Adverse Event
Injury
Summary report: N
SCREW, FIXATION, BONE
MDR report key: 19742719
·
Received July 15, 2024
Report
- Report Number
- 2027754-2024-00038
- Event Type
- Injury
- Date Received
- July 15, 2024
- Report Date
- July 15, 2024
- Manufacturer
- OSTEOMED, LLC
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT HAD A FAILED FUSION (EVENT DATE UNKNOWN), AND AN EXPLANT/REMOVAL SURGERY WAS BEING PERFORMED. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285115 | SCREW, FIXATION, BONE | HWC | OSTEOMED, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |