Brand Name | BHR DYSPLASIA DRILL 3.2MM |
Type of Device | BIT, DRILL |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK CV31 3HL |
|
MDR Report Key | 7315701 |
MDR Text Key | 101716701 |
Report Number | 3005975929-2018-00075 |
Device Sequence Number | 1 |
Product Code |
HTW
|
UDI-Device Identifier | 03596010533562 |
UDI-Public | 03596010533562 |
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,foreig |
Type of Report
| Initial,Followup |
Report Date |
11/23/2018 |
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 | 90127619 |
Device Lot Number | 165390001 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/14/2018 |
Initial Date FDA Received | 03/06/2018 |
Supplement Dates Manufacturer Received | 02/14/2018
|
Supplement Dates FDA Received | 11/23/2018
|
Patient Sequence Number | 1 |
|
|