Brand Name | BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE) |
Type of Device | IMPLANT |
Manufacturer (Section D) |
STRYKER LEIBINGER FREIBURG |
boetzingerstr. 41 |
freiburg D-791 11 |
|
Manufacturer (Section G) |
STRYKER LEIBINGER FREIBURG |
boetzingerstr. 41 |
|
freiburg D-791 11 |
|
Manufacturer Contact |
gregory
gohl
|
boetzingerstr. 41 |
freiburg D-791-11
|
76145120
|
|
MDR Report Key | 7439871 |
MDR Text Key | 106260972 |
Report Number | 0008010177-2018-00034 |
Device Sequence Number | 1 |
Product Code |
JEY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K022185 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
04/18/2018 |
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 | 50-20414 |
Device Lot Number | UNKNOWN, STOCKED SET |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/29/2018
|
Initial Date FDA Received | 04/18/2018 |
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 |
|
|