Brand Name | TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125° |
Type of Device | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Manufacturer (Section D) |
STRYKER TRAUMA KIEL |
prof. kuentscher-strasse 1-5 |
schoenkirchen/kiel D-242 32 |
|
Manufacturer (Section G) |
STRYKER TRAUMA KIEL |
prof. kuentscher-strasse 1-5 |
|
schoenkirchen/kiel D-242 32 |
|
Manufacturer Contact |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 6576580 |
MDR Text Key | 75628967 |
Report Number | 0009610622-2017-00152 |
Device Sequence Number | 1 |
Product Code |
HSB
|
UDI-Device Identifier | 04546540375087 |
UDI-Public | (01)04546540375087(11)160607(17)210531(10)K05DB2B |
Combination Product (y/n) | N |
PMA/PMN Number | K034002 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
05/18/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/18/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2021 |
Device Catalogue Number | 31251200S |
Device Lot Number | K05DB2B |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/02/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/16/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/07/2016 |
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;
|