FDA Adverse Event
Malfunction
Summary report: N
CORE SABER DRILL
MDR report key: 2213849
·
Received August 4, 2011
Report
- Report Number
- 1811755-2011-02808
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 23, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS PENDING. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE OVERHEATED. THIS OCCURRED WHILE THE DEVICE WAS BEING REPAIRED AT THE MFR. THERE WERE NO ADVERSE CONSEQUENCES OR PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE SABER DRILL | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |