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 11G IVAS ACCESS CANNULA 0306330000 manufactured by Stryker Instruments-kalamazoo.
[133540568]
Discarded.
Patient Sequence No: 1, Text Type: N, H10
[133540569]
It was reported that the physicians access cannula placement was too lateral and breached the canal causing cement to leak after the spinejack device was successfully implanted. The leaked cement hardened and an additional procedure was necessary to remove the leaked cement which was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2019-00159 |
| MDR Report Key | 8261211 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-20 |
| 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-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 | 11G IVAS ACCESS CANNULA |
| Generic Name | INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) |
| Product Code | OAR |
| Date Received | 2019-01-18 |
| Catalog Number | 0306330000 |
| 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 |