Brand Name | 2.7 MM CANNULATED DRILL, 160MM |
Type of Device | SURGICAL DRILL BIT |
Manufacturer (Section D) |
ORTHOPEDIATRICS, CORP |
2850 frontier drive |
warsaw, in |
|
Manufacturer (Section G) |
ORTHOPEDIATRICS, CORP |
2850 frontier drive |
|
warsaw, in |
|
Manufacturer Contact |
kriss
anderson
|
2850 frontier drive |
warsaw, in
|
2686379
|
|
MDR Report Key | 10445516 |
MDR Text Key | 207733676 |
Report Number | 3006460162-2020-00095 |
Device Sequence Number | 1 |
Product Code |
HTW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/24/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/24/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 01-1400-1016 |
Device Lot Number | 91905582-A |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/27/2020 |
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 |
Unknown
|
Patient Sequence Number | 1 |
|
|