Brand Name | RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM |
Type of Device | PEDICLE SCREW SPINAL SYSTEM |
Manufacturer (Section D) |
ORTHOPEDIATRICS, CORP |
2850 frontier drive |
warsaw, in |
|
Manufacturer (Section G) |
ORTHOPEDIATRICS, CORP |
2850 frontier drive |
|
warsaw, in |
|
Manufacturer Contact |
leigh
jessop
|
2850 frontier drive |
warsaw, in
|
2670872
|
|
MDR Report Key | 9714167 |
MDR Text Key | 190692958 |
Report Number | 3006460162-2020-00007 |
Device Sequence Number | 1 |
Product Code |
OSH
|
UDI-Device Identifier | 0084113210045 |
UDI-Public | (01)0084113210045(10)200269-L |
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 |
01/27/2020 |
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 Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 00-1300-0735 |
Device Lot Number | 200269-L |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/24/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/10/2020 |
Initial Date FDA Received | 02/14/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/19/2019 |
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 Age | 13 YR |
Patient Weight | 47 |