Brand Name | ROTATING FOOTED ATTACHMENT25MM |
Type of Device | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP |
1941 stryker way |
portage MI 49002 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
|
kalamazoo MI 49001 |
|
Manufacturer Contact |
colette
chung
|
1941 stryker way |
portage, MI 49002
|
2693237700
|
|
MDR Report Key | 17987498 |
MDR Text Key | 326300411 |
Report Number | 3015967359-2023-02202 |
Device Sequence Number | 1 |
Product Code |
HBE
|
UDI-Device Identifier | 07613327096415 |
UDI-Public | 07613327096415 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/23/2023 |
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 Catalogue Number | 5407FA300R |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/30/2023 |
Initial Date FDA Received | 10/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |