MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-18 for PRODISC C OUS TOTAL DISC REPLACEMENT UNKNOWN manufactured by Centinel Spine, Llc..
[187999864]
Limited information was made available regarding this adverse event despite multiple attempts to gather additional information. The only information provided has been x-ray images of an unknown patient. The images are both lateral view images of the cervical spine in flexion and extension. The images show a prodisc c implant. The images appear to depict the superior endplate collapsing into the superior vertebral body as well as anterior migration of the superior endplate. The superior endplate is shown extending past the anterior aspect of the vertebral body. It is not known whether the patient was revised and/or the prodisc c implant has been removed. Patient complications and symptoms were not provided.
Patient Sequence No: 1, Text Type: N, H10
[187999865]
X-ray images were received via a distributor showing a patient with a prodisc c ous implant. The images appear to depict collapse of the superior endplate into the superior vertebral body. The prodisc c superior endplate has also migrated anteriorly beyond the anterior aspect of the vertebral body. There has been no indication of patient complications or symptoms. The migration of the prodisc c device indicates that a revision of this patient would be required based on previous events; however, no further information on the patient has been provided. It is not known if the patient has received a revision and/or removal of the prodisc c device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00005 |
| MDR Report Key | 9721706 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON SMITH |
| Manufacturer Street | 900 AIRPORT RD, SUITE 3B |
| Manufacturer City | WEST CHESTER, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8878839 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODISC C OUS TOTAL DISC REPLACEMENT |
| Generic Name | PROSTHESIS, INTERVERTEBRAL DISC |
| Product Code | MJO |
| Date Received | 2020-02-18 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTINEL SPINE, LLC. |
| Manufacturer Address | 900 AIRPORT RD, SUITE 3B WEST CHESTER, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |