Brand Name | HINTERMANN SERIES H2 TIBIAL ASSEMBLY |
Type of Device | TOTAL ANKLE REPLACEMENT |
Manufacturer (Section D) |
DT MEDTECH, LLC |
111 moffitt street |
mcminnville TN 37110 |
|
Manufacturer Contact |
dustin
leavitt
|
111 moffitt street |
mcminnville, TN 37110
|
8017181353
|
|
MDR Report Key | 10726007 |
MDR Text Key | 212720948 |
Report Number | 3012104767-2020-00003 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K171004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/23/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2023 |
Device Model Number | 422805 |
Device Catalogue Number | 422805 |
Device Lot Number | AAAQX |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 09/23/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/13/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|