Brand Name | CD HORIZON SOLERA SPINAL SYSTEM |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
humacao PR 00792 |
|
Manufacturer (Section G) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
|
humacao PR 00792 |
|
Manufacturer Contact |
tricha
miles
|
1800 pyramid place |
memphis, TN 38132
|
7635140379
|
|
MDR Report Key | 11927333 |
MDR Text Key | 265415874 |
Report Number | 1030489-2021-00731 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 00643169491328 |
UDI-Public | 00643169491328 |
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K143375 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/03/2021 |
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 | 54850016540 |
Device Catalogue Number | 54850016540 |
Device Lot Number | H5598108 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/08/2021 |
Initial Date FDA Received | 06/03/2021 |
Date Device Manufactured | 02/19/2020 |
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 | 10 YR |