MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-04-05 for POWERCURVE NAVIGATING OSTEOTOME 2003-01 PWR-2011L manufactured by Dfine Incorporated.
[41905644]
The device was received within the facility but has not been evaluated. As soon as the final analysis is conducted, a supplemental report is going to be filed with the results.
Patient Sequence No: 1, Text Type: N, H10
[41905805]
Per received report: cement was injected into the vertebrae. However, it did not go across midline so the physician reinserted the powercurve device. The device was fully articulated reaching across the midline with some resistance so the physician tapped in the proximal end with a small mallet. Once fully deployed, the physician tried to remove the device but it was stuck in the hard bone. After a few minutes and several attempts to dislodge the device, the device broke leaving the distal tip in the patient's vertebral body. The piece was in the middle of the vertebral body and was not sticking out at any point, including the pedicle. There was no metal in the soft tissue, all was encased in the bone and was augmented by cement. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[45152411]
The device was received and evaluated. Upon receipt, visual inspection revealed traces of blood on the handle and shaft. Part of the articulating portion of the shaft had broken off of the device. The length of the device was approximately 15 cm, meaning approximately 2 cm of the tip had broken off. Under magnification, longitudinal cuts along the laser cuts were noted which constituted the breakage. The breakage appeared to be a ductile fracture, occurring at the point of the laser cuts designed for articulation. The customer reported event of the tip of the power curve (trademark) breaking, (leaving part of the tip inside the vertebral body) was confirmed. There does not appear to be any indication of a product quality deficiency, and a definite cause for the reported issue cannot be determined. All units are 100% visually inspected and tested for functionality during the manufacturing process. Additionally, a sampling of units is destructively tested to verify the device integrity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2016-00003 |
| MDR Report Key | 5548289 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-04-05 |
| Date of Report | 2016-03-09 |
| Date of Event | 2016-03-09 |
| Date Mfgr Received | 2016-03-09 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-04-05 |
| 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. DANIEL BALBIERZ |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4083219999 |
| Manufacturer G1 | DFINE INCORPORATED |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERCURVE NAVIGATING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2016-04-05 |
| Returned To Mfg | 2016-03-22 |
| Model Number | 2003-01 |
| Catalog Number | PWR-2011L |
| Lot Number | M210806 |
| Device Expiration Date | 2017-10-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INCORPORATED |
| Manufacturer Address | 3047 ORCHARD PARKWAY SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-05 |