Brand Name | OASYS 3.5 X 22MM POLYAXIAL SCREW |
Type of Device | POSTERIOR CERVICAL SCREW SYSTEM |
Manufacturer (Section D) |
STRYKER SPINE-US |
2 pearl court |
allendale NJ 07401 |
|
Manufacturer (Section G) |
STRYKER SPINE-FRANCE |
zone industrielle de marticot |
|
cestas 33610 |
FR
33610
|
|
Manufacturer Contact |
rita
karan
|
2 pearl court |
allendale, NJ 07401
|
2017608000
|
|
MDR Report Key | 18991044 |
MDR Text Key | 338790626 |
Report Number | 0009617544-2024-00031 |
Device Sequence Number | 1 |
Product Code |
NKG
|
UDI-Device Identifier | 04546540371720 |
UDI-Public | 04546540371720 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K151755 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/28/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 48552322 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/04/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 75 YR |
Patient Sex | Male |