MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-03 for 11G IVAS ACCESS CANNULA 0306330000 manufactured by Stryker Instruments-kalamazoo.
[69010690]
It was reported that during a biopsy procedure at the user facility that the handle came off of the access cannula. The procedure was not completed successfully due to the fact that the cannula broke off inside the patient after several attempts to remove it. There was an adverse consequence in that the cannula broke off 10mm below the skin and was cemented into the vertebral body. A clinically significant delay was also reported due to the patient not being released from the hospital until the following day. It was reported that the patient is doing well and not in pain from the device material left behind.
Patient Sequence No: 1, Text Type: D, B5
[113529281]
Patient Sequence No: 1, Text Type: N, H10
[113529282]
It was reported that during a biopsy procedure at the user facility that the handle came off of the access cannula. The procedure was not completed successfully due to the fact that the cannula broke off inside the patient after several attempts to remove it. There was an adverse consequence in that the cannula broke off 10mm below the skin and was cemented into the vertebral body. A clinically significant delay was also reported due to the patient not being released from the hospital until the following day. It was reported that the patient is doing well and not in pain from the device material left behind.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-00703 |
| MDR Report Key | 6375813 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-03 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-02-03 |
| Date Mfgr Received | 2017-09-14 |
| Device Manufacturer Date | 2016-05-14 |
| Date Added to Maude | 2017-03-03 |
| 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. CASEY METZGER |
| 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 HIGHWAY #3, KM 130.2 |
| 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 | 2017-03-03 |
| Returned To Mfg | 2017-02-09 |
| Catalog Number | 0306330000 |
| Lot Number | 16135012 |
| 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 | 1. Required No Informationntervention | 2017-03-03 |