Brand Name | EXP DUAL-INNER SETSCREW |
Type of Device | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD |
Manufacturer (Section D) |
DEPUY SPINE INC |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC) |
50461 west pontiac trail |
|
wixom MI 48393 |
|
Manufacturer Contact |
kara
ditty-bovard
|
325 paramount drive |
raynham, MA 02767
|
6103142063
|
|
MDR Report Key | 12373629 |
MDR Text Key | 268342063 |
Report Number | 1526439-2021-01767 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 10705034070070 |
UDI-Public | 10705034070070 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K160904 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/30/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/26/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 179722000 |
Device Catalogue Number | 179722000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/30/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40MM; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; ROD, 120 MM; ROD, 120 MM; ROD, 480 MM; TI TRANSVERSE CONNECTOR |
Patient Outcome(s) |
Required Intervention;
|