Brand Name | FEMORAL NAIL, A/R, R1500 T2 FEMUR Ø9X340 MM |
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 | 6180372 |
MDR Text Key | 62544320 |
Report Number | 0009610622-2016-00626 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
PMA/PMN Number | K081152 |
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 |
11/25/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/16/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 18280934S |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/25/2016 |
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 | 32 YR |