MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-04 for PRODISC C US TOTAL DISC REPLACEMENT UNKNOWN manufactured by Centinel Spine, Llc..
[188000894]
An unknown patient received a prodisc c implant at an unknown date. The complaint reporter requested a retrieval kit in preparation for a removal procedure scheduled for (b)(6) 2020. The retrieval kit was shipped direct to the hospital hosting the removal as requested. No further information indicating why the device was being removed was provided by the reporter. Attempts to gather additional information have been unsuccessful. There has been no confirmation that the case went ahead as scheduled. There has been no indication of patient symptoms, complications, or harm related to the prodisc c device. There has been no indication of a malfunction of the prodisc c device. Review of the device history records could not be as no part or lot numbers for the device involved were provided. Review of the risk documentation indicates that no new or unknown risks have been identified. The risks identified have been mitigated and determined to be acceptable. There has been no trend or information to suggest a device related problem. The investigation could not determine a cause for this adverse event. If additional information becomes available at a later date, a follow up submission will be completed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188000895]
An unknown patient was scheduled for a prodisc c removal due to unknown reasons on (b)(6) 2020. It is unknown if the case went ahead as scheduled. There has been no indication why the prodisc c device is being removed. There has been no indication of patient harm, symptoms, or injuries. There has been no indication of a device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00013 |
| MDR Report Key | 9786832 |
| Report Source | OTHER |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-03-04 |
| 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 US TOTAL DISC REPLACEMENT |
| Generic Name | PROSTHEIS, INTERVERTEBRAL DISC |
| Product Code | MJO |
| Date Received | 2020-03-04 |
| 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 | 2020-03-04 |