MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-13 for PROPREP BOX CURETTE 03.605.003 manufactured by Synthes, Inc..
[17072776]
Male patient was undergoing posterior lumbar laminectomy of the bilateral lumbar vertebra (l5) and sacral vertebra (s1). Patient also underwent placement of anterior lumbar intervertebral device (l5-s1), anterior spinal arthrodesis (l5-s1), posterior spinal arthrodesis (l5-s1), placement of posterior spinal instrumetation (l5-s1), bone marrow aspiration, harvest of fat graft and placement of fat graft over the dura, and repair of a dural defect. Physician was using a synthes box curette during procedure. The tip of the synthes box curette broke. The tip of the synthes box curette was removed from the surgical site. Device was substituted with a new synthes box curette, and procedure was completed without further incident. Patient was transferred to the recovery room in stable condition. No untoward effects from broken synthes box curette. The broken synthes box curette and tip were washed and bagged and given to the synthes representative. Representatives are to have synthes examine broken synthes box curette.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1971996 |
| MDR Report Key | 1971996 |
| Date Received | 2011-01-13 |
| Date of Report | 2011-01-13 |
| Date of Event | 2011-01-11 |
| Report Date | 2011-01-13 |
| Date Reported to FDA | 2011-01-13 |
| Date Added to Maude | 2011-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPREP BOX CURETTE |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2011-01-13 |
| Returned To Mfg | 2011-01-11 |
| Model Number | 03.605.003 |
| Catalog Number | 03.605.003 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES, INC. |
| Manufacturer Address | 1301 GOSHEN PARKWAY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-13 |