FDA Adverse Event
Malfunction
Summary report: N
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
MDR report key: 4213262
·
Received October 3, 2014
Report
- Report Number
- 3005985723-2014-00161
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- September 10, 2014
- Report Date
- September 10, 2014
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- OLO
- PMA / PMN Number
- K112507
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN CONDUCTED AT MAKO SURGICAL. AN EVALUATION WILL BEGIN ON THE SUSPECT PART (S) ONCE THEY ARE RECEIVED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL RESULTS ARE OBTAINED.
Additional Manufacturer Narrative · 1
THIS IS A SUPPLEMENTAL REPORT TO THE ORIGINAL CORRECTING INFORMATION FROM (B)(4).
Description of Event or Problem · 1
IT WAS NOTICED THAT THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WAS SMOKING AFTER POWERING ON. THIS EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620972 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM | STEREOTAXIC DEVICE, ACCESSORY | OLO | MAKO SURGICAL CORP. | 204000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |