Brand Name | HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT |
Type of Device | ANKLE |
Manufacturer (Section D) |
DT MEDTECH, A VILEX COMPANY |
111 moffitt street |
mcminnville TN 37110 |
|
Manufacturer (Section G) |
DT MEDTECH, A VILEX COMPANY |
111 moffitt street |
|
mcminnvill TN 37110 |
|
MDR Report Key | 17206182 |
MDR Text Key | 317909151 |
Report Number | 3012104767-2023-00002 |
Device Sequence Number | 1 |
Product Code |
NTG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P160036 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/26/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/26/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Model Number | 301204 |
Device Catalogue Number | 301204 |
Device Lot Number | AABMF |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 05/30/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/27/2022 |
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 | 47 YR |
Patient Sex | Male |
|
|