Brand Name | ORTHO SOLUTIONS DRILL BITS |
Type of Device | AO QC DRILL BIT 2.5/110/85 (GOLD) |
Manufacturer (Section D) |
ORTHO SOLUTIONS UK LIMITED |
west station business park |
spital road |
maldon, essex, CM9 6 FF |
UK CM9 6FF |
|
Manufacturer (Section G) |
ORTHO SOLUTIONS UK LIMITED |
west station business park |
spital road |
maldon, essex, CM9 6 FF |
UK
CM9 6FF
|
|
Manufacturer Contact |
samuel
chong
|
unit 5, west station business |
spital road |
maldon, essex CM9 6-FF
|
UK
CM9 6FF
|
|
MDR Report Key | 9602143 |
MDR Text Key | 196054494 |
Report Number | 3008951116-2020-00002 |
Device Sequence Number | 1 |
Product Code |
HTW
|
UDI-Device Identifier | 05055662931105 |
UDI-Public | 05055662931105 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K102743 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/17/2020 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/01/2024 |
Device Model Number | OS200125 |
Device Catalogue Number | OS200125 |
Device Lot Number | 1A1347 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/17/2019 |
Initial Date FDA Received | 01/17/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/01/2019 |
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 |
Patient Outcome(s) |
Other;
|