Brand Name | DUAL ACTION ROD GRIPPERS |
Type of Device | ROD GRIPPERS |
Manufacturer (Section D) |
ORTHOPEDIATRICS, CORP |
2850 frontier drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ORTHOPEDIATRICS, CORP |
2850 frontier drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
james
gunnels
|
2850 frontier drive |
warsaw, IN 46582
|
|
MDR Report Key | 15786160 |
MDR Text Key | 307515813 |
Report Number | 3006460162-2022-00039 |
Device Sequence Number | 1 |
Product Code |
LXH
|
Combination Product (y/n) | Y |
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 |
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 Model Number | 01-1003-6290 |
Device Catalogue Number | 01-1003-6290 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/13/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Patient Sequence Number | 1 |
Patient Age | 12 YR |
Patient Sex | Female |
|
|