MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-11 for 080-1420-3/0 manufactured by Symmetrysurgical, Inc..
[82471344]
Patient Sequence No: 1, Text Type: N, H10
[82471345]
During anterior cervical discectomy and fusion (acdf) in operating room, the tip of a curette broke off while in use by doctor. The surgical site and room were searched. The curette was found in the suction filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6787725 |
| MDR Report Key | 6787725 |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-08-08 |
| Report Date | 2017-08-09 |
| Date Reported to FDA | 2017-08-09 |
| Date Reported to Mfgr | 2017-08-09 |
| Date Added to Maude | 2017-08-11 |
| 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 | 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 | 3 |
| Generic Name | CURETTE, OPERATIVE |
| Product Code | EKE |
| Date Received | 2017-08-11 |
| Model Number | 080-1420-3/0 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRYSURGICAL, INC. |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-11 |