Brand Name | UNKNOWN SHOULDER LOCKING SCREW |
Type of Device | SHOULDER LOCKING SCREW |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
MDR Report Key | 11036043 |
MDR Text Key | 222284111 |
Report Number | 1818910-2020-26842 |
Device Sequence Number | 1 |
Product Code |
KWS
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Type of Report
| Initial,Followup |
Report Date |
11/23/2020 |
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 Catalogue Number | UNK SHOULDER LOCKING SCREW |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/08/2020 |
Initial Date Manufacturer Received |
11/23/2020
|
Initial Date FDA Received | 12/18/2020 |
Supplement Dates Manufacturer Received | 02/19/2021
|
Supplement Dates FDA Received | 02/24/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | DXTEND GLENOSPHERE STD D42MM; DXTEND HIGHMO PE CUP D42 +3MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 2 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X36MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; DXTEND GLENOSPHERE STD D42MM; DXTEND HIGHMO PE CUP D42 +3MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 2 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X36MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW |
Patient Outcome(s) |
Required Intervention;
|