Brand Name | BHR PLAN CUTTER SMALL |
Type of Device | PROSTHESIS, HIP, SMI-CNSTRAINED, MET/MET, RESURFACING |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa warwickshire CV31 3HL |
UK CV31 3HL |
|
MDR Report Key | 10131043 |
MDR Text Key | 194462450 |
Report Number | 3005975929-2020-00183 |
Device Sequence Number | 1 |
Product Code |
NXT
|
Combination Product (y/n) | N |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Type of Report
| Initial,Followup |
Report Date |
10/16/2020 |
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 | 90127614 |
Device Lot Number | UNKNOWN |
Initial Date Manufacturer Received |
05/12/2020 |
Initial Date FDA Received | 06/08/2020 |
Supplement Dates Manufacturer Received | 10/14/2020
|
Supplement Dates FDA Received | 10/16/2020
|
Patient Sequence Number | 1 |
|
|