MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-07-07 for VERTECOR MIDLINE OSTEOTOME 3.0 1620 manufactured by Dfine Inc..
[1998038]
The midline osteotome got stuck on the threads of a previously placed pedicle screw. The articulating tip broke off and was retained in the vertebra of the pt.
Patient Sequence No: 1, Text Type: D, B5
[9145683]
Other lot of vertecor midline osteotome 3. 0 may be: lot#: tlm-1011-08, dom: 11/12/2010, exp date: 11/30/2011. The vertecor mlo got stuck in the threads of a pre-existing pedicle screw and broke within the vertebral body. The physicians felt it is best to leave the tip embedded in cement and that it would cause no problems to the pt. (b)(4). A review of the device history records did not reveal any anomaly related to the complaint. Prior to release of the lot, mechanical tests were performed and test results for the lot met all specs. No definitive conclusion can be made as the implanted portion of the device is not available for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2011-00005 |
| MDR Report Key | 2197322 |
| Report Source | 07 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-06-08 |
| Date Mfgr Received | 2011-06-10 |
| Device Manufacturer Date | 2010-11-05 |
| Date Added to Maude | 2011-09-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 OSTEOTOME 3.0 |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2011-07-07 |
| Model Number | 1620 |
| Catalog Number | 1620 |
| Lot Number | TLM-1011-02 |
| Device Expiration Date | 2011-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INC. |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-07 |