MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-05-19 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME 0987 manufactured by Dfine Inc..
[5836120]
After 3 passes the midline osteotome became stuck in hard sclerotic bone during cavity creation and was not able to be removed. After repeated attempts to try to remove the device, the outer sleeve of the midline osteotome broke off and remained in the patient's vertebral body and pedicle.
Patient Sequence No: 1, Text Type: D, B5
[13283487]
A review of the material specifications (b)(4), the material of the vertecor midline osteotome 3. 0, pn3765 confirmed that the tip of the device is made from medical grade 316 stainless steel; similar to pedicle screws, commonly used as permanent implants in fusion spine surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00005 |
| MDR Report Key | 4798153 |
| Report Source | 05,07 |
| Date Received | 2015-05-19 |
| Date of Report | 2015-05-19 |
| Date of Event | 2015-04-22 |
| Date Mfgr Received | 2015-04-22 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT FOUNDS |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4083219999 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLINE CEMENT STAGING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2015-05-19 |
| Returned To Mfg | 2015-04-27 |
| Model Number | NA |
| Catalog Number | 0987 |
| Lot Number | M209037 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INC. |
| Manufacturer Address | 3047 ORCHARD PARKWAY SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-19 |