Brand Name | RHEAD, RADIAL IMPLANT, STANDARD STEM, SIZE 2 |
Type of Device | RHEAD, RADIAL IMPLANT, STANDARD STEM, SIZE 2 |
Manufacturer (Section D) |
SMALL BONE INNOVATIONS/ STRYKER/ MILLSTONE MEDICAL |
|
|
MDR Report Key | 7027283 |
MDR Text Key | 92142686 |
Report Number | MW5073265 |
Device Sequence Number | 1 |
Product Code |
KWI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
11/09/2017 |
3 Devices were Involved in the Event: |
1
2
3
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/13/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Expiration Date | 05/31/2019 |
Device Model Number | RHA-S2 |
Device Catalogue Number | RHA-S2 |
Device Lot Number | 9884-601E |
Was Device Available for Evaluation? |
No
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
Disability;
|
Patient Weight | 48 |
|
|