FDA Adverse Event
Injury
Summary report: N
ACCELSTIM
MDR report key: 22569918
·
Received July 22, 2025
Report
- Report Number
- 2183449-2025-00023
- Event Type
- Injury
- Date Received
- July 22, 2025
- Date of Event
- July 11, 2025
- Report Date
- July 22, 2025
- Manufacturer
- ORTHOFIX US LLC
- Product Code
- LOF
- UDI-DI
- 08050040997213
- PMA / PMN Number
- P210035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE WITH NO GOOD RESULTS. A REVIEW OF THE DHR WAS PERFORMED - ALL 100 UNITS FROM THE WORK ORDER PASSED FINAL INSPECTION. SHOULD THE DEVICE RETURN FOR INVESTIGATION, FAILURE ANALYSIS WILL BE COMPLETED.
Description of Event or Problem · 0
THE PATIENT CLAIMED THE DEVICE RAISED HER BLOOD PRESSURE CAUSED HER TO GO TO THE EMERGENCY ROOM. ON (B)(6) 2025, A CALL WAS MADE TO THE PATIENT TO GAIN ADDITIONAL INFORMATION. PATIENT DECLINED TO PROVIDE ADDITIONAL DETAILS REGARDING HER EXPERIENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2295074 | ACCELSTIM | BONE GROWTH STIMULATOR | LOF | ORTHOFIX US LLC | 654300-0001 | 08050040997213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Required Intervention |