Brand Name | PRECICE PLATING SYSTEM |
Type of Device | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Manufacturer (Section D) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise dr, suite 100 |
aliso viejo CA 92656 |
|
MDR Report Key | 12044921 |
MDR Text Key | 262899955 |
Report Number | 3006179046-2021-00316 |
Device Sequence Number | 1 |
Product Code |
KTT
|
UDI-Device Identifier | 00887517021366 |
UDI-Public | 887517021366 |
Combination Product (y/n) | N |
PMA/PMN Number | K192181 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
08/17/2021 |
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 | LP4.5-PRF4B |
Device Lot Number | 0072003AAA |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/03/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/01/2021 |
Initial Date FDA Received | 06/22/2021 |
Supplement Dates Manufacturer Received | 08/16/2021
|
Supplement Dates FDA Received | 08/17/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 8 YR |
|
|