Brand Name | STR PLT 8HLE 2.0 LACTOSORB SYS |
Type of Device | CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE |
Manufacturer (Section D) |
BIOMET MICROFIXATION |
1520 tradeport drive |
jacksonville FL 32218 |
|
Manufacturer (Section G) |
BIOMET MICROFIXATION |
1520 tradeport drive |
|
jacksonville FL 32218 |
|
Manufacturer Contact |
jennifer
delaney
|
1520 tradeport drive |
jacksonville, FL 32218
|
9047414400
|
|
MDR Report Key | 12960090 |
MDR Text Key | 285231358 |
Report Number | 0001032347-2021-00542 |
Device Sequence Number | 1 |
Product Code |
HRS
|
UDI-Device Identifier | 00841036054528 |
UDI-Public | (01)00841036054528(17)260115(10)819430 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K955729 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/08/2021 |
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 | 915-2108 |
Device Lot Number | 819430 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/14/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/23/2021 |
Initial Date FDA Received | 12/08/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/15/2021 |
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 |