FDA Adverse Event
Injury
Summary report: N
JAZZ
MDR report key: 9852259
·
Received March 19, 2020
Report
- Report Number
- 3007675554-2020-00001
- Event Type
- Injury
- Date Received
- March 19, 2020
- Date of Event
- February 11, 2020
- Report Date
- March 12, 2020
- Manufacturer
- IMPLANET
- Product Code
- OWI
- PMA / PMN Number
- K170730
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
FOR UNKNOWN REASON A PATIENT WAS REVISED ON (B)(6) 2020. DURING THIS NEW SURGERY, THE PHYSICIAN TOOK OUT A JAZZ BAND BECAUSE IT WAS BROKEN. INITIAL SURGERY WAS ON (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319892 | JAZZ | JAZZ BAND | OWI | IMPLANET | 150156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |