MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-04 for MOBI-C P&F IMPLANT 19X19 H05 MB2995 manufactured by Ldr Medical.
[178195840]
Common device name is similar to mobi-c cervical disc prosthesis. Pma number is similar to p110009. This device is not cleared within the us, but is similar to mb3995. The device was not returned, but photos of x-rays were provided and used for analysis purposes. The cause is likely attributed to a use error associated with the improper selection of implant size and/or patient due to the patient having a previous fusion above this level. A review of the manufacturing records did not identify any issues that would have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[178195841]
It was reported that a revision surgery was performed to address a disc replacement device that migrated six weeks post-operatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2020-00014 |
| MDR Report Key | 9666918 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2014-11-10 |
| Date Added to Maude | 2020-02-04 |
| 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 P&F IMPLANT 19X19 H05 |
| Generic Name | SEE H10 |
| Product Code | MJO |
| Date Received | 2020-02-04 |
| Model Number | NA |
| Catalog Number | MB2995 |
| Lot Number | 080888 |
| Device Expiration Date | 2019-09-01 |
| 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. Required No Informationntervention | 2020-02-04 |