Brand Name | INFINITY TRI-CAM |
Type of Device | DENTAL IMPLANT |
Manufacturer (Section D) |
ACE SURGICAL |
1034 pearl st |
brockton MA 02301 |
|
Manufacturer (Section G) |
ACE SURGICAL |
1034 pearl st |
|
brockton MI 02301 |
|
Manufacturer Contact |
eileen
carpentieri
|
1034 pearl st |
brockton, MA 02301
|
8004413100
|
|
MDR Report Key | 17822026 |
MDR Text Key | 324319155 |
Report Number | 1287163-2023-02273 |
Device Sequence Number | 1 |
Product Code |
DZE
|
UDI-Device Identifier | 00614950005222 |
UDI-Public | 00614950005222 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K10379000614 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
08/08/2023 |
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
|
Device Model Number | 304310 |
Device Catalogue Number | 304310 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/11/2023 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/26/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 | 18 YR |
Patient Sex | Prefer Not To Disclose |
|
|