Brand Name | ENDO. XENO GRAN. .5ML,500-1000 |
Type of Device | BONE GRAFTING MATERIAL, SYNTHETIC |
Manufacturer (Section D) |
BIOMET FRANCE S.A.R.L. |
plateau de lautagne bp75 |
valence cedex 26903 |
FR 26903 |
|
Manufacturer (Section G) |
BIOMET FRANCE S.A.R.L. |
plateau de lautagne bp75 |
|
valence cedex 26903 |
FR
26903
|
|
Manufacturer Contact |
elisabeth
plane
|
plateau de lautagne bp75 |
valence cedex 26903
|
FR
26903
|
0334757591
|
|
MDR Report Key | 5773395 |
MDR Text Key | 48917642 |
Report Number | 3006946279-2016-00209 |
Device Sequence Number | 1 |
Product Code |
LYC
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | PK110449 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Dentist
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
06/06/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/06/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Dentist
|
Device Expiration Date | 04/30/2017 |
Device Model Number | N/A |
Device Catalogue Number | ROX05 |
Device Lot Number | T0291134 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/06/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/27/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | FR 2015-03 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|