MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for DIAMOND COBB ELEVATOR 2029-18 manufactured by Acromed/depuy Spiine.
[71904331]
A (b)(6) male underwent an anterior lumbar interbody fusion l4-l5 and l5-s1 levels. During surgery a diamond cobb elevator was being used (by orthopedic surgeon) and while maneuvering the instrument it broke in half with a residual part remaining in the disk space. The remaining piece was removed by the orthopedic surgeon, and upon removal, the left common iliac vein and left external iliac vein were lacerated. This warranted a surgical intervention (by vascular surgeon) for repair of both lacerated veins. Post repair, bleeding was under control, and orthopedic surgeon proceeded with completion of the intended orthopedic procedure. Patient had 1 unit of packed cells in recovery. On (b)(6) 2017- patient was stable and discharged home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068895 |
| MDR Report Key | 6459781 |
| Date Received | 2017-04-03 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-29 |
| Date Added to Maude | 2017-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIAMOND COBB ELEVATOR |
| Generic Name | ELEVATED LARGE 3/4IN HEAD DIAM |
| Product Code | HTE |
| Date Received | 2017-04-03 |
| Model Number | 2029-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACROMED/DEPUY SPIINE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-03 |