Brand Name | ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE |
Type of Device | INTERVERTEBRAL BODY FUSION DEVICE |
Manufacturer (Section D) |
STRYKER SPINE-US |
2 pearl court |
allendale NJ 07401 |
|
Manufacturer (Section G) |
STRYKER SPINE-US |
2 pearl court |
|
allendale NJ 07401 |
|
Manufacturer Contact |
christa
marrow
|
2 pearl court |
allendale, NJ 07401
|
2017608000
|
|
MDR Report Key | 6358177 |
MDR Text Key | 68350996 |
Report Number | 3004024955-2017-00013 |
Device Sequence Number | 1 |
Product Code |
MAX
|
UDI-Device Identifier | 07613327068054 |
UDI-Public | (01)07613327068054 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143616 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/26/2017 |
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? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | 305008 |
Device Lot Number | 09231502 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/28/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/30/2017 |
Initial Date FDA Received | 02/24/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/26/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/09/2015 |
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 | 36 YR |
Patient Weight | 118 |