Brand Name | TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM |
Type of Device | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 8643501 |
MDR Text Key | 146262250 |
Report Number | 1020279-2019-02065 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
PMA/PMN Number | K111025 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
11/14/2019 |
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 | 71645027 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/05/2019 |
Initial Date FDA Received | 05/27/2019 |
Supplement Dates Manufacturer Received | 05/05/2019 09/27/2019
|
Supplement Dates FDA Received | 06/18/2019 11/14/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 71645032; 71645037; 71645042; 71645047; 71645052; 71645057; 71645062; 71645067; 71645072; 71645077 |
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