MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for PRODISC C MILLING BIT 03.820.167 manufactured by Centinel Spine Llc.
[181527642]
Pt admitted for elective surgery of a cervical five-cervical six discectomy and disc replacement. Prior to the placement of the prodisc-c cervical implant, the milling bit tip broke (approx 16mm in length). Lateral x-rays were normal, anterior-posterior (ap) x-rays (c-arm) revealed metallic milling bit piece inferior of the cervical 6 vertebrae midline. The cervical cage implant was removed and surgeon retrieved the milling bit piece. The procedure was then converted to a cervical 5-cervical six fusion. A dural tear was noted during surgery but it is unk if the broken milling bit had caused the tear. Surgeon repaired the tear. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093297 |
| MDR Report Key | 9754080 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-06 |
| Date Added to Maude | 2020-02-26 |
| 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 | 3 |
| Brand Name | PRODISC C MILLING BIT |
| Generic Name | PROSTHESIS, INTEBERTEBRAL DISC |
| Product Code | MJO |
| Date Received | 2020-02-25 |
| Model Number | 03.820.167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTINEL SPINE LLC |
| Manufacturer Address | WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-02-25 |