Brand Name | 2.5 CALIBRATED DRILL BIT |
Type of Device | BIT, DRILL |
Manufacturer (Section D) |
ORTHOPEDIATRICS, INC |
2850 frontier drive |
warsaw, in |
|
Manufacturer (Section G) |
ORTHOPEDIATRICS, INC |
2850 frontier drive |
|
warsaw, in |
|
Manufacturer Contact |
leigh
jessop
|
2850 frontier drive |
warsa, in
|
2670872
|
|
MDR Report Key | 9742959 |
MDR Text Key | 190698274 |
Report Number | 3006460162-2019-00031 |
Device Sequence Number | 1 |
Product Code |
HTW
|
Combination Product (Y/N) | N |
Reporter Country Code | SP |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
DISTRIBUTOR,FOREIGN,HEALTH PR |
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
07/06/2019 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 02/23/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | N/A |
Device Catalogue Number | 01-1050-0032 |
Device LOT Number | 00SKA-L |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 06/06/2019 |
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
|
|
|