Brand Name | MMF SCREW |
Type of Device | FIXATION SCREW |
Manufacturer (Section D) |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
kolbinger strabe 10 |
muhlheim/donau, 78570 |
GM 78570 |
|
Manufacturer (Section G) |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
kolbinger strabe 10 |
|
muhlheim/donau, 78570 |
GM
78570
|
|
Manufacturer Contact |
jennifer
damato
|
p.o. box 16369 |
jacksonville, FL 32245
|
9046417746
|
|
MDR Report Key | 5198677 |
MDR Text Key | 30297769 |
Report Number | 9610905-2015-00053 |
Device Sequence Number | 1 |
Product Code |
DZL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083432 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/22/2015 |
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 Model Number | 25-092-52-91 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/15/2015
|
Initial Date FDA Received | 11/03/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/05/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
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;
|
Patient Age | 40 YR |
|
|