Brand Name | DXTEND SCREW LOCK D4.5X24MM |
Type of Device | DELTA XTEND IMPLANTS : SCREWS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY INT'L LTD. 8010379 |
st. anthony's rd |
|
leeds LS11 8 DT |
UK
LS11 8 DT
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12820642 |
MDR Text Key | 280828522 |
Report Number | 1818910-2021-25200 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 10603295027836 |
UDI-Public | 10603295027836 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120174 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/27/2021 |
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 | 130790024 |
Device Catalogue Number | 130790024 |
Device Lot Number | 5336529 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/27/2021
|
Initial Date FDA Received | 11/16/2021 |
Supplement Dates Manufacturer Received | 11/25/2021
|
Supplement Dates FDA Received | 11/29/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2019 |
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 |
Treatment | DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND STAND PE CUP D38 +6MM; METAGLENE LONG PEG +10MM; UNK SHOULDER HUMERAL STEM DELTA XTEND; XTND GLENO D38MM +2MM |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |
Patient Sex | Female |