Brand Name | MCK TIBIAL BASEPLATE-LM/RL-SZ 6 |
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 |
diana
rogers
|
210 centennial avenue |
centennial park, elstree |
borehamwood WD6 3-SJ
|
UK
WD6 3SJ
|
2082386500
|
|
MDR Report Key | 16193445 |
MDR Text Key | 307559753 |
Report Number | 3005985723-2023-00008 |
Device Sequence Number | 1 |
Product Code |
NPJ
|
UDI-Device Identifier | 00848486000721 |
UDI-Public | 00848486000721 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090763 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/18/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/18/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 180606 |
Device Catalogue Number | 180606 |
Device Lot Number | 26570917-01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/21/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 88 YR |
Patient Sex | Male |