Brand Name | LOCKING SCREW |
Type of Device | PEDINAIL |
Manufacturer (Section D) |
ORTHOPEDIATRICS, CORP |
2850 frontier drive |
warsaw, in |
|
Manufacturer (Section G) |
ORTHOPEDIATRICS, INC |
2850 frontier drive |
|
warsaw, in |
|
Manufacturer Contact |
leigh
jessop
|
2850 frontier drive |
warsaw, in
|
2670872
|
|
MDR Report Key | 9721967 |
MDR Text Key | 190696107 |
Report Number | 3006460162-2020-00023 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083726 |
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 |
02/11/2020 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/05/2019 |
Initial Date FDA Received | 02/18/2020 |
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 Weight | 50 |
|
|