MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-01-21 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME 0987 manufactured by Dfine Inc..
[1205753]
Physician inserted the midline cement staging osteotome through the working cannula into the vertebra of t10 in the left pedicle. Upon attempting to remove the osteotome embedded in the bone, the articulating tip of the osteotome had broken off during the removal process and remains in the body of the vertebra.
Patient Sequence No: 1, Text Type: D, B5
[8147474]
The implanted portion of the device is made from (b) (4). Physician stated that the patient is at no risk of injury, as the device is manufactured from (b) (4) and the device is completely contained within the confines of the vertebra. Physician stated that the patient had extremely sclerotic dense bone. A review of the device history record did not reveal any anomaly related to the complaint. Prior to release of the lot, torque and tensile tests were performed. Torque and tensile test results for the lot met all specifications/ instructions for use for the vertecor straightline osteotome has been updated. Product will be investigated if returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2009-00003 |
| MDR Report Key | 1360692 |
| Report Source | 07 |
| Date Received | 2009-01-21 |
| Date of Report | 2009-01-21 |
| Date of Event | 2009-01-15 |
| Date Mfgr Received | 2009-01-15 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2010-01-04 |
| 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 | 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 CEMENT STAGING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2009-01-21 |
| Model Number | 0987 |
| Catalog Number | 0987 |
| Lot Number | CSM-0812-05 |
| Device Expiration Date | 2009-06-30 |
| 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 | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-21 |