Brand Name | PIVOX OBLIQUE LATERAL SPINAL SYSTEM |
Type of Device | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
Manufacturer (Section D) |
MEDTRONIC SOFAMOR DANEK USA, INC |
4340 swinea rd |
memphis TN 38118 |
|
Manufacturer (Section G) |
MEDTRONIC SOFAMOR DANEK USA, INC |
4340 swinea rd |
|
memphis TN 38118 |
|
Manufacturer Contact |
stacie
ziemba
|
1800 pyramid place |
memphis, TN 38132
|
9013963133
|
|
MDR Report Key | 8334414 |
MDR Text Key | 136022030 |
Report Number | 1030489-2019-00134 |
Device Sequence Number | 1 |
Product Code |
OVD
|
UDI-Device Identifier | 00643169639607 |
UDI-Public | 00643169639607 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K152277 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/15/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/13/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 2161001 |
Device Lot Number | NM18G004 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/12/2019 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/25/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/20/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 71 YR |