Brand Name | BIOHORIZONS INTERNAL 3.5MM TITANIUM BASE ABUTMENT |
Type of Device | INTERNAL 3.5MM TITANIUM BASE ABUTMENT |
Manufacturer (Section D) |
BIOHORIZONS, INC. |
2300 riverchase center |
birmingham 35244 |
|
Manufacturer (Section G) |
BIOHORIZONS, INC. |
2300 riverchase center |
|
birmingham 35244 |
|
Manufacturer Contact |
anissa
smith
|
2300 riverchase center |
birmingham 35244
|
2059867880
|
|
MDR Report Key | 7822101 |
MDR Text Key | 118537418 |
Report Number | 1060818-2018-00078 |
Device Sequence Number | 1 |
Product Code |
NHA
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/27/2018 |
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 | PYTB |
Device Lot Number | 1504069 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/29/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/29/2018 |
Initial Date FDA Received | 08/28/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/15/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |