MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-21 for PRODISC C TOTAL DISC REPLACEMENT UNKNOWN manufactured by Centinel Spine, Llc..
[188001680]
The patient required removal of the prodisc c device due to pain associated with loosening and migration of the superior endplate. The cause of the endplate loosening is not known. There were no indications of patient comorbidities. The prodisc c device was implanted sometime in 2014 and removed on (b)(6) 2020. There was no indication of a device failure. Part and lot numbers were not provided as the device was not made available for retrieval after removal from the patient. Risks associated with this complaint were identified, mitigated, and deemed to be acceptable. The probability of occurrence for these risks was found to be within expected limits. The investigation could not determine a cause for this event. If additional information becomes available, a follow up submission to this report may be made as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188001681]
A patient with a prodisc c total disc replacement implanted at an unknown date in 2014, required a revision surgery to remove the prodisc c device. The patient was experiencing pain as a result of the superior endplate loosening and migration. The prodisc c implant was removed and replaced with an acdf.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00011 |
| MDR Report Key | 9740657 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODISC C TOTAL DISC REPLACEMENT |
| Generic Name | PROSTHESIS, INTERVERTEBRAL DISC |
| Product Code | MJO |
| Date Received | 2020-02-21 |
| 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 | 2020-02-21 |