MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-28 for REVOLUTION CEMENT GUN 0606600000 manufactured by Stryker Instruments-kalamazoo.
[182040272]
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events 16 events were reported for this quarter. Product return status 8 devices were received. 8 device investigation types have not yet been determined. Event confirmation status 8 reported events were confirmed. Evaluation results 8 devices were found to be affected by internal corrosion. Additional information 16 devices were not labeled for single-use. 16 devices were not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[182040273]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00178 |
| MDR Report Key | 9636501 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVOLUTION CEMENT GUN |
| Generic Name | MIXER, CEMENT, FOR CLINICAL USE |
| Product Code | JDZ |
| Date Received | 2020-01-28 |
| Model Number | 0606600000 |
| Catalog Number | 0606600000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |