Brand Name | STRAIGHT MAGNUM INSERTER 1/4-28 THREADED ROD KIT |
Type of Device | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Manufacturer (Section D) |
BIOMET ORTHOPEDICS |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
BIOMET ORTHOPEDICS |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 6211012 |
MDR Text Key | 63469287 |
Report Number | 0001825034-2016-05425 |
Device Sequence Number | 1 |
Product Code |
LXH
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | PEXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/11/2018 |
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 |
Physician
|
Device Model Number | N/A |
Device Catalogue Number | S313142 |
Device Lot Number | ZB150601 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/21/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/28/2016
|
Initial Date FDA Received | 12/28/2016 |
Supplement Dates Manufacturer Received | Not provided 01/10/2018
|
Supplement Dates FDA Received | 01/20/2017 01/11/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/12/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |