Brand Name | HINTERMANN SERIES H3 TOTAL ANKLE - TALAR COMPONENT |
Type of Device | COATED TALAR COMPONENT |
Manufacturer (Section D) |
DT MEDTECH LLC |
111 moffitt street |
mcminnville TN 37110 |
|
Manufacturer (Section G) |
DT MEDTECH LLC |
111 moffitt street |
|
mcminnville TN 37110 |
|
Manufacturer Contact |
|
111 moffitt street |
mcminnville, TN 37110
|
|
MDR Report Key | 12263731 |
MDR Text Key | 264702987 |
Report Number | 3012104767-2021-00002 |
Device Sequence Number | 1 |
Product Code |
NTG
|
UDI-Device Identifier | B0953011131 |
UDI-Public | +B0953011131/$$7AAAKO/14D20240628D |
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 |
distributor,foreign,other |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
08/03/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/02/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/08/2021 |
Device Model Number | 301113 |
Device Catalogue Number | 301113 |
Device Lot Number | AAAKO |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 07/08/2021 |
Was Device Evaluated by Manufacturer? |
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 | 64 YR |