MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-14 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME 0987 manufactured by Dfine Inc..
[5720215]
Working in the acetabulum of the pelvis in extremely hard bone due to prostate cancer. The physician entered using the stabilit introducer and bone drill; the midline osteotome was then used to make a channel to follow the spinestar. After advancing the midline osteotome, it became stuck. Numerous techniques were tried to remove the midline osteotome, with it finally giving way and was removed. Upon the removal, the outer sheath had come off the midline and was still lodged inside the patient's bone. A general surgeon was called to assist in the removal, where a larger cut in the patient's buttocks was made and the surgeon removed the sheath. When looking the patient over, it appeared that the tip of the midline osteotome was still lodged in the patient's sclerotic bone less than 1-2mm, it was decided to leave the piece inside that patient; and then the physician continued with the ablation and augmentation.
Patient Sequence No: 1, Text Type: D, B5
[13160868]
Dhr review: pn 3353, stabilit first fracture kit (blister pack), revision ag, lot 140609a01 ((b)(4)). Pn 3352, first fracture kit, blister pack, short devices, revision ad, lot 140430a01 ((b)(4)). Pn 1688, stabilit er2 bone cement and saturate mixing system, revision ac, lot df048 ((b)(4)). Trv 3476 / pn 3354, inner tray assembly, first fracture kit, short, blister pack (lz form), revision ad, lot sfk-1404-03 / r2120a ((b)(4)). Pn 2482, assembly of vertecor midline cement staging osteotome 3. 0-11. 5, short, lz-form, revision ab, lot tsm-1403-31 ((b)(4)). No anomalies were related to the customer complaint (b)(4) upon review of the dhr documentation. Evaluation of device: 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. Investigation of the midline osteotome confirmed the device was broken and the tip of the device missing (remained in patient).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00004 |
| MDR Report Key | 4703731 |
| Report Source | 05,07 |
| Date Received | 2015-04-14 |
| Date of Report | 2015-04-06 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-03-27 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-06-01 |
| 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 | 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 | 2015-04-14 |
| Returned To Mfg | 2015-04-08 |
| Model Number | NA |
| Catalog Number | 0987 |
| Lot Number | TSM-1403-31 |
| ID Number | NA |
| Device Expiration Date | 2015-08-31 |
| 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 | 2015-04-14 |