MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for VERTECOR MIDLINE CEMENT SAGING OSTEOTOME 1620 manufactured by Dfine Inc..
[23323862]
The device has not been received within our facility for evaluation. Upon receipt of the unit, a final analysis will be conducted and a supplemental report is going to be submitted.
Patient Sequence No: 1, Text Type: N, H10
[23323863]
Per received report: the midline osteotome (mlo) was used on 2 levels, l2 and l3. It broke and was unable to articulate during use in the second level. The articulating portion became misshapen. The physician had difficulty removing the mlo and nearly lost access. The physician chose to deliver the cement without the desired amount of cavities. He ultimately went bipedicular. The case was successfully completed with no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[29983569]
The device has been received and an investigation was conducted. The customer reported event of the device being broken or misshapen could not be confirmed as no kink, bend or slight deformation was noted at the tip or any part of the shaft of the device. The tip retained its shape as functional testing was performed. The device was examined under a microscope under 0. 7x magnification and the unit did not reveal any indication of any part being broken or misshapen as what the initial report had indicated. The articulation portion of the device appeared normal and passed all functional testing criteria. Although there does not appear to be any indication of a product quality deficiency, a definitive cause for the reported issue cannot be determined. All units are 100% visually inspected and tested for its functionality during the manufacturing process. Only passing units are moved to the next process. Additionally, a sampling of units is destructively tested to verify the midline osteotome's (mlo) integrity. A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00008 |
| MDR Report Key | 4964035 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-07-06 |
| Date Mfgr Received | 2015-09-18 |
| Device Manufacturer Date | 2014-08-27 |
| Date Added to Maude | 2015-08-04 |
| 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 | DAN BALBIERZ |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 951340000 |
| Manufacturer Country | US |
| Manufacturer Postal | 951340000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLINE CEMENT SAGING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2015-07-31 |
| Returned To Mfg | 2015-08-17 |
| Model Number | NA |
| Catalog Number | 1620 |
| Lot Number | TLM-1408-26 |
| ID Number | NA |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 951340000 US 951340000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |