Brand Name | BIOSURE SYNC |
Type of Device | BIOSURE SYNC,9-10MM ,TIBIAL FIX |
Manufacturer (Section D) |
MANSFIELD MANUFACTURING SITE |
130 forbes boulevard |
mansfield MA 02048 |
|
Manufacturer (Section G) |
MANSFIELD MANUFACTURING SITE |
130 forbes boulevard |
|
mansfield MA 02048 |
|
Manufacturer Contact |
robert
bombard
|
150 minuteman road |
andover, MA 01810
|
9787491561
|
|
MDR Report Key | 3613623 |
MDR Text Key | 4070697 |
Report Number | 1219602-2014-00034 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
01/09/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/07/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2018 |
Device Model Number | 72202746 |
Device Catalogue Number | 72202746 |
Device Lot Number | 50472520 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/27/2014 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Device Age | 6 MO |
Event Location |
Hospital
|
Date Manufacturer Received | 01/09/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/21/2013 |
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) |
Required Intervention;
|