MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-13 for PRODISC C US IMPLANT UNKNOWN manufactured by Centinel Spine, Llc..
[187999743]
A pdc removal case was reportedly scheduled for (b)(6) 2020. Instruments and a retrieval kit were provided to support the case. There was no initial indication of a device problem, patient complications, or other reason for the pdc removal. The case was completed on schedule. No further information is available for this case. Device history review and device evaluation could not be performed. The dfmea for this device was reviewed with no indication of new or unknown risks. Identified risks have been indicated to be mitigated as far as reasonably practicable and/or the benefits outweigh the risk. The device could not be retrieved for unknown reasons from the case despite a kit being provided. If additional information becomes available at a later date this complaint may be updated.
Patient Sequence No: 1, Text Type: N, H10
[187999744]
A notification was received through a distributor that a prodisc c implant removal was scheduled for (b)(6) 2020. The reason for the removal has been requested but not provided by the surgeon. It is not known if the patient was experiencing complications in relation to the device. The case was completed on (b)(6) 2020; however, no further information is known about the case or patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00008 |
| MDR Report Key | 9707120 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-13 |
| 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 IMPLANT |
| Generic Name | PROSTHESIS, INTERVERTEBRAL DISC |
| Product Code | MJO |
| Date Received | 2020-02-13 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-02-13 |