Brand Name | INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM |
Type of Device | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Manufacturer (Section D) |
MDT PUERTO RICO OPERATIONS CO, MED REL |
road 909, km. 0.4., barrio mar |
humacao PR 00792 |
|
Manufacturer (Section G) |
MDT PUERTO RICO OPERATIONS CO, MED REL |
road 909, km. 0.4., barrio mar |
|
humacao PR 00792 |
|
Manufacturer Contact |
tricha
miles
|
1800 pyramid place |
memphis, TN 38132
|
7635140379
|
|
MDR Report Key | 11100016 |
MDR Text Key | 224530228 |
Report Number | 2647346-2020-00050 |
Device Sequence Number | 1 |
Product Code |
KWP
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K163375 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/31/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/31/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | G3600315 |
Device Catalogue Number | G3600315 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/10/2020 |
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 |
|
|