Brand Name | FITBONE |
Type of Device | INTRAMEDULLARY LENGTHENING NAIL |
Manufacturer (Section D) |
WITTENSTEIN INTENS GMBH |
walter-wittenstein-strasse 1 |
igersheim, 97999 |
GM 97999 |
|
Manufacturer Contact |
nadine
kohlhepp
|
walter-wittenstein-strasse 1 |
igersheim 97999
|
GM
97999
|
|
MDR Report Key | 11796433 |
MDR Text Key | 252246480 |
Report Number | 3003236810-2021-00004 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K163368 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Remedial Action |
Inspection |
Type of Report
| Initial |
Report Date |
04/20/2021 |
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 Model Number | TAA1180-T245 |
Device Catalogue Number | 60001348 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/22/2021 |
Initial Date FDA Received | 05/10/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/09/2021 |
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 |
|
|