MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-01 for 11 GAUGE VERTE PORT CEMENT CANNULA REF 0306-511-000 manufactured by Stryker Instruments.
[76853473]
End of kyphoplasty procedure handle of 11 gauge verteport cement cannula broke leaving metal delivery catheter in vertebral body l1. Sterile pliers used for removal. Patient was informed of difficult cannula removal. No other complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070173 |
| MDR Report Key | 6614115 |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-05-31 |
| Date Added to Maude | 2017-06-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | 11 GAUGE VERTE PORT CEMENT CANNULA |
| Generic Name | 11 GAUGE VERTE PORT CEMENT CANNULA |
| Product Code | OAR |
| Date Received | 2017-06-01 |
| Catalog Number | REF 0306-511-000 |
| Lot Number | SS319110116350126X |
| Device Expiration Date | 2019-01-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-01 |