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 2016-02-26 for POWERCURVE NAVIGATING OSTEOTOME 4421 manufactured by Dfine Incorporated.
[39198948]
The device is in the process of evaluation. As soon as the investigation has been conducted, a final analysis report report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[39198949]
The physician was treating a patient with a 3 to 6 month old bone fracture. The bone was described as significantly dense and sclerotic. During the procedure, a couple of cavities were successfully created when the tip of the powercurve broke and part of the tip was left inside the vertebral body. The physician did not perform any additional intervention to remove the broken part. The tip remained in the vertebra and was augmented by cement. Additional information received from the sales representative indicated that the procedure was completed by removing and replacing the introducer and was able to deliver the cement. Approximately 2cm was left in the vertebral body. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[44807503]
When received, the unit was not in its original packaging. Traces of blood were observed on the handle and shaft of the device. Initial observation revealed that part of the articulating portion of the shaft had broken off of the device. The length of the device shaft upon receipt was approximately 14 cm, meaning approximately 3 cm of the tip had broken off. Under magnification, the breakage appeared to be a ductile fracture, occurring at the point of laser cuts designed for device articulation. The unit was disassembled. Investigation revealed slight deformation of the threads on the male thread actuator. No additional discrepancies with other components were noted. Conclusion: the customer reported event of the tip of the power curve 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 definitive 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 | 3006396387-2016-00001 |
| MDR Report Key | 5463887 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-03 |
| Date of Event | 2016-02-03 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-02-26 |
| 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 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4087701150 |
| 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 | 2016-02-26 |
| Returned To Mfg | 2016-02-18 |
| Catalog Number | 4421 |
| Lot Number | PWL-1509-28 |
| Device Expiration Date | 2017-09-30 |
| 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 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-26 |