Brand Name | TI LOCKING SCREW - STERILE |
Type of Device | ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION |
Manufacturer (Section D) |
OBERDORF SYNTHES PRODUKTIONS GMBH |
eimattstrasse 3 |
oberdorf 4436 |
SZ 4436 |
|
Manufacturer (Section G) |
SYNTHES SELZACH |
bohackerweg 5 |
|
selzach 2545 |
SZ
2545
|
|
Manufacturer Contact |
kara
ditty-bovard
|
1302 wrights lane east |
west chester, PA 19380
|
6107195000
|
|
MDR Report Key | 10148731 |
MDR Text Key | 194967656 |
Report Number | 8030965-2020-04135 |
Device Sequence Number | 1 |
Product Code |
NKG
|
UDI-Device Identifier | 07611819328747 |
UDI-Public | (01)07611819328747 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K142838 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/01/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/12/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 04.614.508S |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/01/2020 |
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 | UNK - PLATES: SPINE; UNK - RODS: SYNAPSE |
Patient Outcome(s) |
Required Intervention;
|