MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-09-01 for VERTECOR MIDLINE OSTEOTOME 3.0 1620 manufactured by Dfine Inc..
[2157500]
International affiliate reports that it was difficult to remove a midline osteotome from a patient. Although the device was completely removed from the patient, the procedure duration was extended by approximately 3 hours and additional anesthesia was administered to the patient. A medwatch report is being submitted to document the event.
Patient Sequence No: 1, Text Type: D, B5
[9476799]
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 specifications. It is unknown what caused difficulty in removing the midline osteotome from the patient. If additional information is received, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2011-00007 |
| MDR Report Key | 2253186 |
| Report Source | 99 |
| Date Received | 2011-09-01 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-08-04 |
| Device Manufacturer Date | 2010-09-23 |
| Date Added to Maude | 2012-06-28 |
| 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 951340000 |
| Manufacturer Country | US |
| Manufacturer Postal | 951340000 |
| Manufacturer G1 | DFINE INC. |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95134 0000 |
| 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 | 2011-09-01 |
| Returned To Mfg | 2011-08-18 |
| Model Number | 1620 |
| Catalog Number | 1620 |
| Lot Number | TLM-1009-20 |
| Device Expiration Date | 2011-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-09-01 |