Brand Name | UNKNOWN TITANIUM ASNIS III SCREW |
Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
SZ 2545 |
|
Manufacturer (Section G) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
SZ
2545
|
|
Manufacturer Contact |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 16227909 |
MDR Text Key | 307941875 |
Report Number | 0008031020-2023-00028 |
Device Sequence Number | 1 |
Product Code |
HWC
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/23/2023 |
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 |
Lay User/Patient
|
Device Catalogue Number | UNK_SEL |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/28/2022 |
Initial Date FDA Received | 01/23/2023 |
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 Outcome(s) |
Required Intervention;
|
Patient Age | 19 YR |
Patient Sex | Male |
Patient Weight | 85 KG |
|
|