Brand Name | 6.5 CANCELLOUS BONE SCREW 35MM |
Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
|
mahwah NJ 07430 |
|
Manufacturer Contact |
collin
neitzel
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 9145845 |
MDR Text Key | 162105038 |
Report Number | 0002249697-2019-03358 |
Device Sequence Number | 1 |
Product Code |
HWC
|
UDI-Device Identifier | 07613327037012 |
UDI-Public | 07613327037012 |
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | K894124 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/02/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2022 |
Device Catalogue Number | 2030-6535-1 |
Device Lot Number | W80NDPR |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/06/2019 |
Initial Date FDA Received | 10/02/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/30/2017 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 77 YR |
Patient Weight | 72 |