Brand Name | RAPIDFLAP SPINDOWN CLAMP 12 MM 12-PACK |
Type of Device | PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE |
Manufacturer (Section D) |
BIOMET MICROFIXATION |
1520 tradeport drive |
jacksonville FL 32218 |
|
Manufacturer (Section G) |
BIOMET MICROFIXATION |
1520 tradeport drive |
|
jacksonville FL 32218 |
|
Manufacturer Contact |
michelle
cole
|
1520 tradeport drive |
jacksonville, FL 32218
|
9047414400
|
|
MDR Report Key | 6754295 |
MDR Text Key | 81413624 |
Report Number | 0001032347-2017-00603 |
Device Sequence Number | 1 |
Product Code |
GXN
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | PK031034 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/26/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/25/2020 |
Device Model Number | N/A |
Device Catalogue Number | 75-1020-12 |
Device Lot Number | 381140 |
Other Device ID Number | SEE H10 NARRATIVE |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/14/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/04/2017 |
Initial Date FDA Received | 07/31/2017 |
Supplement Dates Manufacturer Received | 08/14/2017 02/22/2018
|
Supplement Dates FDA Received | 09/13/2017 02/26/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/25/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|