Brand Name | 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 44MM-STERILE |
Type of Device | APPLIANCE, FIXATION, NAIL |
Manufacturer (Section D) |
WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
1302 wrights lane east |
west chester PA 19380 |
|
Manufacturer (Section G) |
WERK MEZZOVICO (CH) |
via cavazz 5 |
|
mezzovico 6805 |
SZ
6805
|
|
Manufacturer Contact |
kara
ditty-bovard
|
1302 wrights lane east |
west chester, PA 19380
|
6103142063
|
|
MDR Report Key | 10852819 |
MDR Text Key | 216662541 |
Report Number | 2939274-2020-05190 |
Device Sequence Number | 1 |
Product Code |
KTT
|
UDI-Device Identifier | 10886982275431 |
UDI-Public | (01)10886982275431 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K000682 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/21/2020 |
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 |
Health Professional
|
Device Model Number | 412.216S |
Device Catalogue Number | 412.216S |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/21/2020 |
Initial Date FDA Received | 11/17/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | ANTIROTATION SCREW FOR FNS 100MM - STERILE; BOLT FOR FNS 95MM LENGTH-STERILE; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE |
Patient Outcome(s) |
Required Intervention;
|
Patient Weight | 67 |