Brand Name | REAMER HANDLE, OFFSET |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MAKO SURGICAL CORP. |
3365 enterprise ave |
weston FL 33331 |
|
Manufacturer (Section G) |
MAKO SURGICAL CORP. |
3365 enterprise ave |
|
weston FL 33331 |
|
Manufacturer Contact |
sanjana
talathi
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 18595315 |
MDR Text Key | 333964719 |
Report Number | 3005985723-2024-00015 |
Device Sequence Number | 1 |
Product Code |
OLO
|
UDI-Device Identifier | 00848486032142 |
UDI-Public | 00848486032142 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141989 |
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 |
03/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/29/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 212760 |
Device Lot Number | 5368824 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 02/13/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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;
|
|
|