Brand Name | TIBIAL INSERT ONLAY TRIAL-SIZE 4-8MM |
Type of Device | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM |
Manufacturer (Section D) |
MAKO SURGICAL CORP. |
2555 davie road |
fort lauderdale FL 33317 |
|
Manufacturer (Section G) |
MAKO SURGICAL CORP. |
2555 davie road |
|
fort lauderdale FL 33317 |
|
Manufacturer Contact |
keyla
colon
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 6269783 |
MDR Text Key | 65527784 |
Report Number | 3005985723-2017-00033 |
Device Sequence Number | 1 |
Product Code |
NPJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/25/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 170704-1 |
Device Lot Number | 12021115 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/10/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/09/2017
|
Initial Date FDA Received | 01/23/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/25/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/17/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|