Brand Name | METAGLENE POSITIONER PLATE |
Type of Device | ALIGNMENT DEVICES |
Manufacturer (Section D) |
DEPUY FRANCE SAS 3003895575 |
7 allée irène joliot curie |
bp 256 |
saint priest cedex 69801 |
FR 69801 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDIC INC, 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582
|
5743725905
|
|
MDR Report Key | 7218101 |
MDR Text Key | 98230550 |
Report Number | 1818910-2018-51988 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 10603295116448 |
UDI-Public | 10603295116448 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K170748 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/08/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 230787003 |
Device Lot Number | 6209916 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/07/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/08/2018
|
Initial Date FDA Received | 01/25/2018 |
Supplement Dates Manufacturer Received | 02/07/2018 06/29/2018
|
Supplement Dates FDA Received | 02/12/2018 07/17/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 68 YR |