MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-28 for PRODISC L POLYETHYLENE INLAY W/TANTALUM MARKER LARGE 10MM PDL-L-PT10S manufactured by Centinel Spine, Llc..
[176769490]
Information provided by the reporter indicates the prodisc l inferior endplate migrated anteriorly. Images of the patient indicated the patient suffered a pedicle fracture when they felt the described "pop" sensation. The surgeon indicated they did have any information indicating how the fracture or migration occurred. It is not known if the migration may have caused or contributed to the pedicle fracture. It is not known if the fracture may have caused or contributed to the device migration. Review of device history records did not indicate any issues in manufacturing that would have caused or contributed to this event. The risks associated with the reported event are identified within the risk assessment for this device. There has been no indication in a trend of complaints to suggest corrective action is necessary. The device was successfully retrieved, and as of this report is under evaluation by a third party testing laboratory.
Patient Sequence No: 1, Text Type: N, H10
[176769491]
Patient underwent revision surgery to remove a prodisc l construct from the l5-s1 disc space. The patient experienced a "pop" sensation due to unknown circumstances post operatively. The patient was experiencing pain when lying down. The surgeon discovered via x-ray that the patient suffered a pedicle fracture, and the prodisc l inferior endplate had migrated anteriorly. The surgeon determined medical intervention was required to remove the prodisc l construct and replace it with an alif using midline ii-ti cage and midline abo screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00002 |
| MDR Report Key | 9638552 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2017-12-21 |
| Date Added to Maude | 2020-01-28 |
| 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 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 4848878839 |
| Manufacturer G1 | SYNTHES BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODISC L POLYETHYLENE INLAY W/TANTALUM MARKER LARGE 10MM |
| Generic Name | PROSTHESIS, INTERVERTEBRAL DISC |
| Product Code | MJO |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-01-08 |
| Model Number | PDL-L-PT10S |
| Lot Number | H436470 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTINEL SPINE, LLC. |
| Manufacturer Address | 900 AIRPORT RD, SUITE 3B WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |