MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2014-10-27 for RHOTON 80-1689 manufactured by Symmetry Surgical.
[5002068]
During a surgery of the cervical spine called "frykrolm" she tick the longitudinal band to touch or mobilize an intervertebral disk sequester. A small piece 2mm of the tip got stuck in the band. The facility in (b)(6) reported to (b)(6): during a surgery of the cervical spine called "frykrolm" she tick the longitudinal band to touch or mobilize a intervertebral disk sequester. A small piece 2mm of the tip got stuck in the band. Remedial action taken by the healthcare facility relevant to the care of the patient: prof. (b)(6) informed the patient that from her medical point of view there is no risk and she didn't expect any complications. Device tip broke during surgery, device was not returned to symmetry surgical for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2014-00017 |
| MDR Report Key | 4218676 |
| Report Source | 00,01,06 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-10-23 |
| Date of Event | 2014-08-04 |
| Date Mfgr Received | 2014-10-21 |
| Date Added to Maude | 2014-11-14 |
| 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 Contact | CHRIS SMITH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 370130000 |
| Manufacturer Country | US |
| Manufacturer Postal | 370130000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHOTON |
| Generic Name | NERVE HOOK |
| Product Code | GZT |
| Date Received | 2014-10-27 |
| Model Number | 80-1689 |
| Catalog Number | 80-1689 |
| ID Number | 00887482031476 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL |
| Manufacturer Address | ANTIOCH TN 37013000 US 37013 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-27 |