MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-18 for PRODISC L US PDL-L-SP11S manufactured by Synthes Brandywine.
[188001887]
The information provided by the reporter confirmed the initial assessment that the patient required medical intervention to preclude serious injury. The expulsion of the pe inlay may have been causing or contributing to the patient's pain. It was reported the patient had osteopenia; however, there was no indication if this caused or contributed to the migration/expulsion of the prodisc l inlay. The risk assessment identified 2 risks associated with inlay expulsion. There was no indication of new or unknown risks based on the information provided. Review of complaints determined the complaint rate is within allowable limits established in the dfmea. There are no capas associated with this complaint. Review of the pictures and x-rays provided confirmed inlay expulsion. The investigation could not determine a cause for this adverse event. The device was successfully retrieved and assigned pdl-rd-002 by the third party laboratory. If pertinent information becomes available from the retrieval testing, this report may be updated as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188001888]
Patient was reported to have low back pain which was caused or contributed to by the patient's prodisc l us implant. Imaging of the prodisc l device found the prodisc l pe inlay had expelled from the inferior endplate. Surgical intervention to remove the prodisc l implant was performed on (b)(6) 2020. The patient was converted to a fusion via unknown device from l4 through s1. The prodisc l device was implanted at l5-s1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00015 |
| MDR Report Key | 9849292 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-18 |
| 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 L US |
| Generic Name | PROSTHESIS, INTERVERTEBRAL DISC |
| Product Code | MJO |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-25 |
| Model Number | PDL-L-SP11S |
| Lot Number | 6143417 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BRANDYWINE |
| Manufacturer Address | 1303 GOSHEN PARKWAY WEST CHESTER, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |