Brand Name | MANTIS REDUX BLOCKER |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
STRYKER SPINE-FRANCE |
zone industrielle de marticot |
cestas 33610 |
FR 33610 |
|
Manufacturer (Section G) |
STRYKER SPINE-FRANCE |
zone industrielle de marticot |
|
cestas 33610 |
FR
33610
|
|
Manufacturer Contact |
marta
koutsogiannis
|
2 pearl court |
allendale, NJ 07401
|
2017608000
|
|
MDR Report Key | 6891780 |
MDR Text Key | 87291115 |
Report Number | 0009617544-2017-00364 |
Device Sequence Number | 1 |
Product Code |
MNI
|
UDI-Device Identifier | 04546540671431 |
UDI-Public | (01)04546540671431 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K092631 |
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 |
01/03/2018 |
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 Model Number | 48289999 |
Device Catalogue Number | 48289999 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/28/2017
|
Initial Date FDA Received | 09/25/2017 |
Supplement Dates Manufacturer Received | 08/28/2017
|
Supplement Dates FDA Received | 01/03/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 61 YR |
|
|