Brand Name | PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM |
Type of Device | POSTERIOR CERVICO-THORACIC FIXATION SYSTEM |
Manufacturer (Section D) |
SPINE WAVE, INC. |
3 enterprise drive |
suite 210 |
shelton CT 06484 |
|
Manufacturer (Section G) |
SPINE WAVE, INC. |
3 enterprise drive |
suite 210 |
shelton CT 06484 |
|
Manufacturer Contact |
ronald
smith
|
3 enterprise drive |
suite 210 |
shelton, CT 06484
|
2039449494
|
|
MDR Report Key | 7130989 |
MDR Text Key | 95329020 |
Report Number | 3004638600-2017-00009 |
Device Sequence Number | 1 |
Product Code |
NKG
|
UDI-Device Identifier | 10840642111217 |
UDI-Public | 10840642111217 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162369 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/20/2017 |
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 |
Physician
|
Device Catalogue Number | 11-8999 |
Device Lot Number | 662R165 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/22/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/20/2017
|
Initial Date FDA Received | 12/19/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/28/2017 |
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 | 69 YR |