FDA Adverse Event
Malfunction
Summary report: N
ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR
MDR report key: 20270388
·
Received September 19, 2024
Report
- Report Number
- MW5159833
- Event Type
- Malfunction
- Date Received
- September 19, 2024
- Report Date
- September 18, 2024
- Manufacturer
- HIGHRIDGE MEDICAL, LLC. / ZIMMER BIOMET
- Product Code
- LOF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
DIDN'T WORK EFFECTIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1525656 | ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR | STIMULATOR, BONE GROWTH, NON-INVASIVE | LOF | HIGHRIDGE MEDICAL, LLC. / ZIMMER BIOMET | M51896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |