Brand Name | FIBERGRAFT BG MATRIX |
Type of Device | RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE |
Manufacturer (Section D) |
PROSIDYAN, INC. |
41 spring street |
suite 107 |
new providence NJ 07974 |
|
Manufacturer (Section G) |
PROSIDYAN, INC. |
41 spring street |
suite 107 |
new providence NJ 07974 |
|
Manufacturer Contact |
sophia
yiantsos
|
41 spring street |
suite 107 |
new providence, NJ 07974
|
|
MDR Report Key | 17988283 |
MDR Text Key | 326309361 |
Report Number | 3011015097-2023-00049 |
Device Sequence Number | 1 |
Product Code |
MQV
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K180080 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/23/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/25/2023
|
Initial Date FDA Received | 10/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Other;
Required Intervention;
|
Patient Age | 59 YR |
Patient Sex | Male |
Patient Weight | 159 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |