D
Patient 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THERE WAS BLACK RESIDUE OBSERVED IN THE CEMENT. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES REPORTED.
MAUDE MDR 7515324
- MDR report key
- 7515324
- Report number
- 0001811755-2018-00987
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-04-18
- Date received
- 2018-05-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. ZACH BAKER
- Address
- 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US
- Phone
- 269-269-2693
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE | MIXER, CEMENT, FOR CLINICAL USE | STRYKER INSTRUMENTS-KALAMAZOO | JDZ | 0606563000 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-15 | 0 |