Brand Name | HOLDING SLEEVE-LONG FOR MATRIX |
Type of Device | MISC ORTHO SURGICAL INSTR |
Manufacturer (Section D) |
WRIGHTS LANE: SYNTHES USA PRODUCTS LLC |
1302 wrights lane east |
west chester PA 19380 |
|
Manufacturer (Section G) |
MONUMENT |
1101 synthes avenue |
|
monument CO 80132 |
|
Manufacturer Contact |
michael
cote
|
1302 wright lane east |
west chester, PA 19380
|
6107195000
|
|
MDR Report Key | 7224741 |
MDR Text Key | 98642119 |
Report Number | 2939274-2018-50408 |
Device Sequence Number | 1 |
Product Code |
LXH
|
UDI-Device Identifier | 10705034718941 |
UDI-Public | (01)10705034718941(10)H236302 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
12/06/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 03.632.036 |
Device Lot Number | H236302 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/19/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/22/2018
|
Initial Date FDA Received | 01/29/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/24/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |