MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-17 for MOBI-C P&F IMPLANT 17X19 H5 MB2795 manufactured by Ldr M?dical.
[187557258]
This device is not cleared for use within the us; however it is similar to a device that is cleared for use within the us. Common device name: this is similar to mobi-c cervical disc prosthesis. Pma/510(k) number: this is similar to p110009. The explanted device was returned to the manufacturer. However, a full evaluation was unable to be performed since the necessary decontamination records were not provided. The provided x-ray shows the inferior plate has migrated, and the core has also likely migrated. A visual inspection of the device did not identify any obvious indications of damage or malfunction. The cause cannot be determined with the available information. A review if the manufacturing records did not identify any issues that would have contributed to this event. The device's labeling provides instructions on proper site preparation and device installation.
Patient Sequence No: 1, Text Type: N, H10
[187557259]
It was reported that a revision surgery was performed to remove a mobi-c device at c5/6 that had been implanted for about 2 months because of device migration that was causing left arm pain and weakness. A competitor's product was installed during the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2020-00036 |
| MDR Report Key | 9845910 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2018-07-06 |
| Date Added to Maude | 2020-03-17 |
| 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 M |
| 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 P&F IMPLANT 17X19 H5 |
| Generic Name | SEE H10 |
| Product Code | MJO |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2019-03-12 |
| Model Number | NA |
| Catalog Number | MB2795 |
| Lot Number | L082056 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LDR M?DICAL |
| 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. Required No Informationntervention | 2020-03-17 |