MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for REVOLUTION CEMENT MIXING SYSTEM 0606-563-000 manufactured by Stryker Instruments.
[178145950]
The bottom portion of stryker revolution cement mixing system broke off during the mixing of cement. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092804 |
| MDR Report Key | 9676977 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-02-01 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVOLUTION CEMENT MIXING SYSTEM |
| Generic Name | MIXER, CEMENT, FOR CLINICAL USE |
| Product Code | JDZ |
| Date Received | 2020-02-05 |
| Model Number | 0606-563-000 |
| Catalog Number | 0606-563-000 |
| Lot Number | 19253012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |