| Brand Name | ELITE 7CM MODIFIED STRAIGHT 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 | 17719507 |
|---|
| MDR Text Key | 323068961 |
|---|
| Report Number | 3015967359-2023-01935 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
HBE
|
| UDI-Device Identifier | 07613327504026 |
|---|
| UDI-Public | 07613327504026 |
|---|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | US |
|---|
| PMA/PMN Number | K190172 |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
Company Representative |
|---|
| Reporter Occupation |
Other
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
09/11/2023 |
|---|
| 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 Operator |
Health Professional
|
|---|
| Device Catalogue Number | 5407120440 |
|---|
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
|---|
| Date Returned to Manufacturer | 08/22/2023 |
|---|
| Initial Date Manufacturer Received |
08/16/2023
|
|---|
| Initial Date FDA Received | 09/11/2023 |
|---|
| Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
|---|
| Date Device Manufactured | 08/23/2021 |
|---|
| 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 |
|---|
