Brand Name | DXTEND SCREW NO LOCK D4.5X18MM |
Type of Device | DELTA XTEND IMPLANTS : SCREWS |
Manufacturer (Section D) |
DEPUY FRANCE SAS - 3003895575 |
7 allee irene joliot-curie |
b.p. 256 |
saint priest cedex 69801 |
FR 69801 |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg ringaskiddy |
|
cork |
EI
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
b.p. 256 |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7935931 |
MDR Text Key | 122724967 |
Report Number | 1818910-2018-71383 |
Device Sequence Number | 1 |
Product Code |
HSD
|
UDI-Device Identifier | 10603295027782 |
UDI-Public | 10603295027782 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K062250 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
09/11/2018 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 130770018 |
Device Lot Number | 5266392 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/11/2018 |
Initial Date FDA Received | 10/04/2018 |
Supplement Dates Manufacturer Received | 11/01/2018
|
Supplement Dates FDA Received | 11/01/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/01/2016 |
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;
|