Brand Name | OLECRANON PLATE VARIAX FOR RIGHT ULNA 3 HOLE / L65MM |
Type of Device | PLATE, FIXATION, BONE |
Manufacturer (Section D) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
CH 2545 |
|
Manufacturer (Section G) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
CH
2545
|
|
Manufacturer Contact |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 7397536 |
MDR Text Key | 104548596 |
Report Number | 0008031020-2018-00269 |
Device Sequence Number | 1 |
Product Code |
HRS
|
UDI-Device Identifier | 07613327088397 |
UDI-Public | (01)07613327088397 |
Combination Product (y/n) | N |
PMA/PMN Number | K141677 |
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 |
04/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/04/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2021 |
Device Model Number | 629363S |
Device Catalogue Number | 629363S |
Device Lot Number | V19359 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/08/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/11/2016 |
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) |
Other;
|
Patient Age | 81 YR |
|
|