Brand Name | 5.5/6.0 RESPONSE POLYAXIAL PEDICLE SCREW 7.0MM X 70MM |
Type of Device | PEDICLE SCREW SPINAL SYSTEM |
Manufacturer (Section D) |
ORTHOPEDIATRICS, INC |
2850 frontier drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ORTHOPEDIATRICS, INC |
2850 frontier drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
leigh
jessop
|
2850 frontier drive |
warsaw, IN 46582
|
5742670872
|
|
MDR Report Key | 8392476 |
MDR Text Key | 139825883 |
Report Number | 3006460162-2019-00007 |
Device Sequence Number | 1 |
Product Code |
OSH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K150600 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/05/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/05/2019 |
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 | 00-1300-2770 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/04/2019 |
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
|
Patient Sequence Number | 1 |