Brand Name | RESPONSE 5.5/6.0 SPINE SYSTEM |
Type of Device | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
Manufacturer (Section D) |
ORTHOPEDIATRICS CORP. |
2850 frontier drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ORTHOPEDIATRICS CORP. |
2850 frontier drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
mark
fox
|
2850 frontier drive |
warsaw, IN 46582
|
5742686379
|
|
MDR Report Key | 5945569 |
MDR Text Key | 54526614 |
Report Number | 3006460162-2016-00004 |
Device Sequence Number | 1 |
Product Code |
OSH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130655 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
08/18/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 00-1300-6051 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/18/2016 |
Initial Date FDA Received | 09/13/2016 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 16 YR |