FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE
MDR report key: 6286964
·
Received January 30, 2017
Report
- Report Number
- 3004893332-2017-00002
- Event Type
- Malfunction
- Date Received
- January 30, 2017
- Date of Event
- November 17, 2016
- Report Date
- January 30, 2017
- Manufacturer
- SPINAL ELEMENTS
- Product Code
- KWQ
- PMA / PMN Number
- K101848
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PHYSICIAN PERFORMED A REVISION SURGERY ON PATIENT TO REMOVE TWO (2) BROKEN SCREWS. ORIGINAL SURGERY WAS PERFORMED IN 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71591 | SAPPHIRE | SAPPHIRE 4.0X14MM SELF DRILLING VARIABLE SCREW | KWQ | SPINAL ELEMENTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |