FDA Adverse Event
Injury
Summary report: N
MCK TIBIAL ONLAY INSERT- SZ 5- 8MM
MDR report key: 4913348
·
Received July 14, 2015
Report
- Report Number
- 3005985723-2015-00122
- Event Type
- Injury
- Date Received
- July 14, 2015
- Date of Event
- June 19, 2015
- Report Date
- June 19, 2015
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- NPJ
- PMA / PMN Number
- K090763
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
THE PATIENT GOT AN INFECTION IN THE OPERATIVE LEG AND DR REPLACED THE POLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454973 | MCK TIBIAL ONLAY INSERT- SZ 5- 8MM | IMPLANT | NPJ | MAKO SURGICAL CORP. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |