Brand Name | SPF SPINAL FUSION STIMULATOR |
Type of Device | IMPLANTABLE STIMULATOR; SPF-XL IIB 2/DM |
Manufacturer (Section D) |
EBI, LLC. |
399 jefferson road |
parsippany NJ 07054 |
|
Manufacturer (Section G) |
EBI, LLC. |
399 jefferson road |
|
parsippany NJ 07054 |
|
Manufacturer Contact |
michelle
cole
|
399 jefferson road |
parsippany, NJ 07054
|
9732999300
|
|
MDR Report Key | 6690971 |
MDR Text Key | 79229095 |
Report Number | 0002242816-2017-00026 |
Device Sequence Number | 1 |
Product Code |
LOE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PP850035 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/06/2017 |
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 |
Health Professional
|
Device Expiration Date | 10/27/2018 |
Device Model Number | N/A |
Device Catalogue Number | 10-1335M |
Device Lot Number | 585-17 |
Other Device ID Number | SEE H10 NARRATIVE |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/06/2017
|
Initial Date FDA Received | 07/06/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/27/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | ZFA 2017-245 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|