Brand Name | TRANSLACE SPINAL TETHERING SYSTEM |
Type of Device | BONE FIXATION CERCLAGE, SUBLAMINAR |
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 |
glen
belmer
|
1800 pyramid place |
memphis, TN 38132
|
6122713209
|
|
MDR Report Key | 14133403 |
MDR Text Key | 289423187 |
Report Number | 1030489-2022-00360 |
Device Sequence Number | 1 |
Product Code |
OWI
|
UDI-Device Identifier | 00643169726925 |
UDI-Public | 00643169726925 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K163181 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/18/2022 |
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 |
Health Professional
|
Device Model Number | 8219500 |
Device Catalogue Number | 8219500 |
Device Lot Number | VS17B004 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/25/2022
|
Initial Date FDA Received | 04/18/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |
Patient Weight | 40 KG |
|
|