MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-28 for PRODISC C TOTAL DISC REPLACEMENT UNKNOWN manufactured by Centinel Spine, Llc..
[187999882]
A patient had a prodisc c removed due to unknown reasons. Patient identification was not provided. The date of implantation and implanting surgeon is unknown. The reason for removal of the prodisc c device is not known. No patient harms, conditions, or symptoms have been provided. Very little information has been provided by the revising surgeon despite attempts to gather additional information. It is believed the patient had the prodisc c removed and a fusion performed within unknown devices as a replacement. The device was not available for retrieval per the hospital. It is unknown what the hospital did with the device. Device history records could not be reviewed as no part and lot numbers were provided. Risks associated with device removal have been identified, mitigated, and deemed acceptable. There has been no indication of a device related problem. The investigation cannot determine a cause for this adverse 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
[187999963]
A patient with an unknown size prodisc c implant was revised on (b)(6) 2020 to remove the prodisc c device. The removal was performed for unknown reasons. The patient was revised to a fusion with unknown devices. The patient outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00012 |
| MDR Report Key | 9769966 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-28 |
| 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 | SYNTHES BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER, PA |
| Manufacturer Country | US |
| 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 | 2020-02-28 |
| 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 | 2020-02-28 |