Brand Name | 3.5MM TI LOCKING SCREW SELF-TAPPING 26MM |
Type of Device | APPLIANCE, FIXATION, NAIL |
Manufacturer (Section D) |
SYNTHES GMBH |
eimattstrasse 3 |
oberdorf 4436 |
SZ 4436 |
|
Manufacturer (Section G) |
WERK HÄGENDORF (CH) |
im bifang 6 |
|
haegendorf 4614 |
SZ
4614
|
|
Manufacturer Contact |
kate
karberg
|
1302 wright lane east |
west chester, PA 19380
|
3035526892
|
|
MDR Report Key | 14044120 |
MDR Text Key | 288809534 |
Report Number | 8030965-2022-02264 |
Device Sequence Number | 1 |
Product Code |
KTT
|
UDI-Device Identifier | 07611819239258 |
UDI-Public | (01)07611819239258 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K000684 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/07/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 413.026 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/11/2022 |
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 | CORTSCR Ø2.4 SELF-TAP L18 TAN; CORTSCR Ø3.5 SELF-TAP L24 TI; DHP 2.7/3.5 DORSO-LAT LE 5HO TI; HSS DRILL BIT Ø3.5 F/IMPLANT STEEL; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L18 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L24 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L28 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L30 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L32 TA; LOCKSCR Ø3.5 SELF-TAP L24 TAN; LOCKSCR Ø3.5 SELF-TAP L26 TAN |
Patient Outcome(s) |
Required Intervention;
|