MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-09 for REVOLUTION CEMENT GUN 0606600000 manufactured by Stryker Instruments-kalamazoo.
[107822273]
It was reported that during testing, the screw fell out at the end of the device. There was no associated procedure and therefore, no patient involvement or adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-00969 |
| MDR Report Key | 7500522 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-09 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-05-09 |
| 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 | 2018-05-09 |
| Returned To Mfg | 2018-04-13 |
| Catalog Number | 0606600000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-09 |