FDA Adverse Event
Malfunction
Summary report: N
MCK TIBIAL BASEPLATE-LM/RL-SZ 6
MDR report key: 4965392
·
Received August 4, 2015
Report
- Report Number
- 3005985723-2015-00139
- Event Type
- Malfunction
- Date Received
- August 4, 2015
- Date of Event
- July 9, 2015
- Report Date
- October 19, 2017
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- NPJ
- PMA / PMN Number
- K090763
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING A PRIMARY LEFT KNEE PROCEDURE, WHEN CIRCULATING NURSE OPENED OUTER BOX FOR THE TIBIAL BASEPLATE, THE STERILE INNER PACKAGING WAS FOUND TO BE TORN THEREBY QUESTIONING THE STERILITY OF THE IMPLANT AND WAS NOT USED IN SURGERY. ANOTHER IMPLANT OF SAME SIZE WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE SURGERY WITHOUT DELAY OR ANY ADVERSE CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509497 | MCK TIBIAL BASEPLATE-LM/RL-SZ 6 | IMPLANT | NPJ | MAKO SURGICAL CORP. | 26080211-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |