Brand Name | BONE CUTTER,5.5MM X 13CM |
Type of Device | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
MDR Report Key | 9443814 |
MDR Text Key | 173454530 |
Report Number | 1220246-2019-01468 |
Device Sequence Number | 1 |
Product Code |
GFA
|
UDI-Device Identifier | 00888867043930 |
UDI-Public | 00888867043930 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
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 |
02/11/2020 |
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 | 08/31/2024 |
Device Model Number | BONE CUTTER,5.5MM X 13CM |
Device Catalogue Number | AR-8550BC |
Device Lot Number | 10378376 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/19/2019 |
Initial Date FDA Received | 12/10/2019 |
Supplement Dates Manufacturer Received | 11/19/2019
|
Supplement Dates FDA Received | 02/11/2020
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|