Brand Name | BIGLIANI FLATOW PEGGED GLENOID |
Type of Device | HSD |
Manufacturer (Section D) |
ZIMMER INC |
p.o. box 708 |
warsaw IN 46581 0708 |
|
Manufacturer Contact |
kevin
escapule
|
p.o. box 708 |
warsaw, IN 46581-0708
|
8006136131
|
|
MDR Report Key | 5486349 |
MDR Text Key | 39884805 |
Report Number | 1822565-2016-00588 |
Device Sequence Number | 1 |
Product Code |
HSD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/10/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/08/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2022 |
Device Catalogue Number | 00430204652 |
Device Lot Number | 62727336 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/10/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/25/2014 |
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;
|
Patient Age | 61 YR |
Patient Weight | 91 |
|
|