Brand Name | XIA LP POLYAXIAL SCREW 5.5 X 40MM |
Type of Device | SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS |
Manufacturer (Section D) |
STRYKER SPINE-SWITZERLAND |
le crêt-du-locle 10 a |
- |
la chaux-de-fonds 2300 |
CH 2300 |
|
Manufacturer (Section G) |
STRYKER SPINE-SWITZERLAND |
le crêt-du-locle 10 a |
- |
la chaux-de-fonds 2300 |
CH
2300
|
|
Manufacturer Contact |
christa
marrow
|
2 pearl court |
allendale, NJ 07401
|
2017608000
|
|
MDR Report Key | 6976222 |
MDR Text Key | 90945158 |
Report Number | 3005525032-2017-00099 |
Device Sequence Number | 1 |
Product Code |
KWQ
|
UDI-Device Identifier | 04546540149176 |
UDI-Public | (01)04546540149176 |
Combination Product (y/n) | N |
PMA/PMN Number | K060361 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/21/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/25/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 03821540 |
Device Catalogue Number | 03821540 |
Device Lot Number | 0036787 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/29/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/21/2012 |
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 Age | 62 YR |