MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-11 for 11G IVAS ACCESS CANNULA 0306330000 manufactured by Stryker Instruments-kalamazoo.
[130019945]
Discarded.
Patient Sequence No: 1, Text Type: N, H10
[130019946]
It was reported that the needle broke off and was stuck in the patient's pedicle. Medical intervention was necessary by enlarging the pedicle hole to remove the device material left behind. A surgical delay of 2 hours was reported. A majority of the broken fragment were retrieved and no additional adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-02756 |
| MDR Report Key | 8153751 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-11 |
| 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 | 2018-12-11 |
| Catalog Number | 0306330000 |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2018-12-11 |