MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-18 for AUTOPLEX SYSTEM: W/ VERTAPLEX 0605687000 manufactured by Stryker Instruments-kalamazoo.
[133540303]
Discarded.
Patient Sequence No: 1, Text Type: N, H10
[133540304]
It was reported by the physician that there was dissatisfaction with the visualization of the cement during the procedure. It was further reported that the cement leaked into the anterior portion of the vertebral body. There were no adverse consequences to the patient and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2019-00158 |
| MDR Report Key | 8261210 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-18 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2019-01-18 |
| 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-PUERTO RICO |
| Manufacturer Street | LAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2 |
| Manufacturer City | ARROYO 00615 |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOPLEX SYSTEM: W/ VERTAPLEX |
| Generic Name | MIXER, CEMENT, FOR CLINICAL USE |
| Product Code | JDZ |
| Date Received | 2019-01-18 |
| Catalog Number | 0605687000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-01-18 |