Brand Name | TORQUE SCREW |
Type of Device | TORQUE SCREW |
Manufacturer (Section D) |
EXACTECH, INC. |
2320 nw 66th court |
gainesville FL 32653 |
|
Manufacturer (Section G) |
EXACTECH, INC. |
2320 nw 66th court |
|
gainesville FL 32653 |
|
Manufacturer Contact |
graham
cuthbert
|
2320 nw 66th court |
gainesville, FL 32653
|
|
MDR Report Key | 7609187 |
MDR Text Key | 111308134 |
Report Number | 1038671-2018-00510 |
Device Sequence Number | 1 |
Product Code |
KWT
|
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 |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
07/26/2018 |
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
|
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/15/2018 |
Initial Date FDA Received | 06/18/2018 |
Supplement Dates Manufacturer Received | 06/15/2018
|
Supplement Dates FDA Received | 07/26/2018
|
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;
|
Patient Age | 52 YR |
Patient Weight | 61 |
|
|