FDA Adverse Event
Malfunction
Summary report: N
TACTILE GUIDANCE SYSTEM V. 2.0
MDR report key: 2123278
·
Received June 3, 2011
Report
- Report Number
- 3005985723-2011-00012
- Event Type
- Malfunction
- Date Received
- June 3, 2011
- Date of Event
- April 18, 2011
- Report Date
- May 18, 2011
- Manufacturer
- MAKO SURGICAL
- Product Code
- HAW
- PMA / PMN Number
- K081867
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION REVEALED THAT THE TIBIAL INACCURACIES WERE THE RESULT OF A ROTATIONAL ERROR IN THE BONE REGISTRATION. IN ADDITION TO THE BONE REGISTRATION, THE SESSION FILE WAS ALSO ANALYZED FOR IRREGULARITIES. THIS ANALYSIS INDICATED THAT NO SOFTWARE ERRORS OCCURRED AND ALL RECORDED IMPLANT POSITIONS WERE CONSISTENT THROUGHOUT THE CASE. IN ADDITION, NO ERRORS WERE FOUND IN THE CRISIS LOGS THAT COULD POTENTIALLY INDICATE A COMMUNICATION OR JOINT MALFUNCTIONING ISSUE.
Description of Event or Problem · 1
TKA CONVERSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TACTILE GUIDANCE SYSTEM V. 2.0 | STEREOTAXIC INSTRUMENT | HAW | MAKO SURGICAL | 0201000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |