FDA Adverse Event
Injury
Summary report: N
TACTILE GUIDANCE SYSTEM V. 2.0
MDR report key: 1851552
·
Received August 18, 2010
Report
- Report Number
- 3005985723-2010-00018
- Event Type
- Injury
- Date Received
- August 18, 2010
- Date of Event
- July 19, 2010
- Report Date
- August 18, 2010
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- HAW
- PMA / PMN Number
- K081867
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS FULLY INVESTIGATED, AN DETERMINED THERE IS NO MALFUNCTION THAT COULD BE IDENTIFIED IN THE SYSTEM AFTER THE EVENT OCCURRED. THE SYSTEM WAS PERFORMING AS EXPECTED IN ALL CASES. THE ROOT CAUSE OF THE REGISTRATION ISSUE WAS DETERMINED TO BE A COMBINATION OF POOR SEGMENTATION AND POOR SURGICAL TECHNIQUE.
Description of Event or Problem · 1
SURGEON WAS UNABLE TO REGISTER THE PT'S ANATOMY. CONVERSION TO TKR PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TACTILE GUIDANCE SYSTEM V. 2.0 | STEREOTAXIC INSTRUMENT | HAW | MAKO SURGICAL CORP. | 0201000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |