Brand Name | ELITE 17CM ANGLED ATTACHMENT |
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 | 19113429 |
MDR Text Key | 341007791 |
Report Number | 3015967359-2024-00836 |
Device Sequence Number | 1 |
Product Code |
HBE
|
UDI-Device Identifier | 07613327096620 |
UDI-Public | 07613327096620 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 3 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/15/2024 |
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 | 5407120486 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/31/2024
|
Initial Date FDA Received | 04/16/2024 |
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 |