FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 SAGITTAL SAW
MDR report key: 2758203
·
Received September 18, 2012
Report
- Report Number
- 1811755-2012-03538
- Event Type
- Malfunction
- Date Received
- September 18, 2012
- Date of Event
- August 24, 2012
- Report Date
- August 27, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD¿L INFO WILL BE SUBMITTED WHEN THE MFR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BACK NUT WAS MISSING WHILE THE EQUIPMENT WAS BEING INSPECTED AT THE STRYKER FOREIGN SUBSIDIARY. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 5 SAGITTAL SAW | KIJ | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |