Brand Name | THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM |
Type of Device | COMPRESSION SCREW, Ø2.7X32MM |
Manufacturer (Section D) |
PEGA MEDICAL INC. |
1111 autoroute chomedey |
laval, quebec H7W 5 J8 |
CA H7W 5J8 |
|
Manufacturer (Section G) |
PEGA MEDICAL INC |
1111 autoroute chomedey |
|
laval, quebec H7W 5 J8 |
CA
H7W 5J8
|
|
Manufacturer Contact |
enrique
garcia
|
1111 autoroute chomedey |
laval, quebec H7W 5-J8
|
CA
H7W 5J8
|
|
MDR Report Key | 10693246 |
MDR Text Key | 211860807 |
Report Number | 3000327445-2020-00006 |
Device Sequence Number | 1 |
Product Code |
KTT
|
UDI-Device Identifier | 07540194005854 |
UDI-Public | (01)07540194005854 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K170704 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
10/16/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/16/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | COMPRESSION SCREW, Ø2.7X32MM |
Device Catalogue Number | POP-OB27-32 |
Device Lot Number | 160714-020 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 09/18/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/06/2017 |
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 | 4 YR |
Patient Weight | 18 |