MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2020-02-26 for MOBI-C IMPLANT, UNKNOWN SIZE manufactured by Ldr Medical.
[187555470]
Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Reference: pitsika, m. , & nissen, j. (2020). Spinal cord compression due to nucleus migration from mobi-c total disc replacement. British journal of neurosurgery, 1? 4. Https://doi. Org/10. 1080/02688697. 2020. 1716942. [pitsika_spinal cord compression due to nucleus migration from mobi-c_br j neurosurg_2020 (002). Pdf].
Patient Sequence No: 1, Text Type: N, H10
[187555471]
It was reported that a patient underwent a revision surgery to remove an implant whose polyethylene core migrated postoperatively causing progressive myelopathy. The surgeon experienced difficulty removing the implant due to severe adhesions of the implant to the dura requiring them to preform a c6/7 vertebrectomy. They placed alternate hardware to complete the case. There were no additional patient impacts reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2020-00020 |
| MDR Report Key | 9754244 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-26 |
| 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 | MS. FLORENCE MAILY |
| Manufacturer Street | QUARTIER EUROPE DE L 5, RUE DE BERLIN |
| Manufacturer City | SAINTE-SAVINE, NA 10300 |
| Manufacturer Country | FR |
| Manufacturer Postal | 10300 |
| Manufacturer Phone | 33382803 |
| Manufacturer G1 | LDR MEDICAL |
| Manufacturer Street | QUARTIER EUROPE DE L 5, RUE DE BERLIN |
| Manufacturer City | SAINTE-SAVINE, NA 10300 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 10300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBI-C IMPLANT, UNKNOWN SIZE |
| Generic Name | MOBI-C CERVICAL DISC PROSTHESIS |
| Product Code | MJO |
| Date Received | 2020-02-26 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LDR MEDICAL |
| Manufacturer Address | QUARTIER EUROPE DE L?OUEST 5, RUE DE BERLIN SAINTE-SAVINE, NA 10300 FR 10300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-02-26 |