Brand Name | STALIF MIDLINE ABO SCREW 6 X 35MM |
Type of Device | INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR |
Manufacturer (Section D) |
CENTINEL SPINE, LLC. |
900 airport rd, suite 3b |
west chester PA 19380 |
|
Manufacturer (Section G) |
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT |
no.9 jingke road, nantun dist. |
|
taichung city, taichung |
TW
|
|
Manufacturer Contact |
jason
smith
|
900 airport rd, suite 3b |
west chester, PA 19380
|
4848878810
|
|
MDR Report Key | 12337985 |
MDR Text Key | 267117518 |
Report Number | 3007494564-2021-00069 |
Device Sequence Number | 1 |
Product Code |
OVD
|
UDI-Device Identifier | 00815101029313 |
UDI-Public | 00815101029313 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K173347 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/10/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/20/2023 |
Device Model Number | STM6035 |
Device Catalogue Number | N/A |
Device Lot Number | 2020-0562 |
Initial Date Manufacturer Received |
07/27/2021 |
Initial Date FDA Received | 08/18/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/09/2020 |
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 Outcome(s) |
Death;
Required Intervention;
|
Patient Age | 46 YR |