MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for TRABIS [K173893] manufactured by Coligne Ag.
[143211373]
Clinical literature cawley, derek t. , et al "carbon-fibre cage reconstruction in anterior cervical corpectomy for multilevel / cervical spondylosis: mid-term outcomes. " journal of spine surgery (2019) reports 102 human subjects underwent cervical corpectomy utilizing trabis k173893; 28. 6% clinically significant device-related subsidence, 25. 4% adjacent-level segment degeneration. Three revision surgeries, five device migrated requiring revision surgeries. Five failed outcomes pseudoarthrosis. During study period, device was not fda approved for cervical indications. Collectively, there were five pseudarthrosis cases where dynamic radiographs displayed >2 mm spinous process differences. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086113 |
| MDR Report Key | 8545900 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-20 |
| Date of Event | 2018-11-28 |
| Date Added to Maude | 2019-04-24 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | TRABIS [K173893] |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE- CERVICAL |
| Product Code | PLR |
| Date Received | 2019-04-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLIGNE AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-04-23 |