Brand Name | ALTEON STEM, SIZE 10, PRESS-FIT TAPERED, EXTENDED OFFSET, 12/14 TAPER |
Type of Device | STEM |
Manufacturer (Section D) |
EXACTECH, INC |
2320 nw 66th ct |
gainesville FL 32653 |
|
Manufacturer (Section G) |
EXACTECH, INC |
2320 nw 66th ct |
|
gainesville FL 32653 |
|
Manufacturer Contact |
graham
cuthbert
|
2320 nw 66th ct |
gainesville, FL 32653
|
3523771140
|
|
MDR Report Key | 5514195 |
MDR Text Key | 40790437 |
Report Number | 1038671-2016-00250 |
Device Sequence Number | 1 |
Product Code |
JDI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/21/2016 |
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 |
Physician
|
Device Catalogue Number | 188-01-10 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/09/2015
|
Initial Date FDA Received | 03/21/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Required Intervention;
|
|
|