Brand Name | FITBONE |
Type of Device | INTRAMEDULLARY LENGTHENING NAIL |
Manufacturer (Section D) |
WITTENSTEIN INTENS GMBH |
walter-wittenstein-str. 1 |
igersheim, 97999 |
GM 97999 |
|
Manufacturer Contact |
eva
lunz
|
walter-wittenstein-str. 1 |
igersheim, baden-wuerttemberg 97999
|
GM
97999
|
|
MDR Report Key | 9887686 |
MDR Text Key | 189497099 |
Report Number | 3003236810-2020-00005 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K163368 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
03/27/2020 |
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 |
Lay User/Patient
|
Device Expiration Date | 09/18/2021 |
Device Model Number | RECEIVER |
Device Catalogue Number | 60001615 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/27/2018 |
Initial Date Manufacturer Received |
10/23/2018 |
Initial Date FDA Received | 03/27/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/18/2018 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 34 YR |
|
|