MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2015-08-31 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME manufactured by Dfine Inc..
[25190951]
The unit has not been received within our facility at this time. As soon as the device is received, an investigation will be conducted and a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[25190952]
A report received from the distributor indicated that the midline osteotome (mlo) was in the shirt when a channel was being created for cement infusion (the bone was described to be a little harder than usual) when it got stuck. As the physician tried to remove it, the mlo broke. There was no additional surgical intervention performed to retrieve the broken piece of the osteotome inside the pt's body. The physician decided to work on the vertebral body with another pedicle and completed the procedure with no report of pt injury. The pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[33152155]
The midline osteotome associated with this complaint was not returned for evaluation. Three follow-up attempts were made to retrieve the device but were unsuccessful. Without the return of the device for analysis and based on the available information, the root cause of the malfunction reported could not be determined. Should this product return at a later date, this complaint will be re-opened and a final analysis will be conducted accordingly. A review of the manufacturing documentation associated with this lot/serial (b)(4) presented no issues during the manufacturing process that can be related to the reported complaint. Therefore, no corrective action is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00012 |
| MDR Report Key | 5057599 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2015-08-31 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-07-07 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-09-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DANIEL |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLINE CEMENT STAGING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2015-08-31 |
| Model Number | NA |
| Lot Number | M209619 |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-08-31 |