MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-08 for 11G IVAS ACCESS CANNULA 0306330000 0306-330-000 manufactured by Stryker Instruments.
[82030080]
Patient Sequence No: 1, Text Type: N, H10
[82030081]
During a sacroplasty and bone biopsy using the stryker 11g access cannula. The needle broke in the patient's bone, and was intentionally left in. Manufacturer response for access cannula, ivas 11g access cannula (per site reporter): unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6773187 |
| MDR Report Key | 6773187 |
| Date Received | 2017-08-08 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-24 |
| Report Date | 2017-08-04 |
| Date Reported to FDA | 2017-08-04 |
| Date Reported to Mfgr | 2017-08-04 |
| Date Added to Maude | 2017-08-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 11G IVAS ACCESS CANNULA |
| Generic Name | INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) |
| Product Code | OAR |
| Date Received | 2017-08-08 |
| Model Number | 0306330000 |
| Catalog Number | 0306-330-000 |
| Lot Number | 17158012 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-08 |