Brand Name | ORTHOPEDIATRICS RESPONSE LARGE SET SCREW |
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 | 8048365 |
MDR Text Key | 126452528 |
Report Number | 3006460162-2018-00071 |
Device Sequence Number | 1 |
Product Code |
OSH
|
UDI-Device Identifier | 0084113210010 |
UDI-Public | (01)0084113210010(10)M86486-B |
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K150600 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/07/2018 |
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 Model Number | N/A |
Device Catalogue Number | 00-1003-4001 |
Device Lot Number | M86486-B |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/08/2018 |
Initial Date FDA Received | 11/07/2018 |
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 | 14 YR |
Patient Weight | 55 |