MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-27 for IMPLANT MOBIC M ST 13X15 H6 US MB3356 manufactured by Ldr Medical.
[187556321]
Without a product return, no product evaluation is able to be conducted. 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.
Patient Sequence No: 1, Text Type: N, H10
[187556322]
It was reported that a patient underwent a revision surgery to remove an implant that migrated postoperatively. The implant was removed using a tonsil clamp and was replaced with alternate hardware. There were no reported additional patient impacts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2020-00019 |
| MDR Report Key | 9766328 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-27 |
| 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 | IMPLANT MOBIC M ST 13X15 H6 US |
| Generic Name | MOBI-C CERVICAL DISC PROSTHESIS |
| Product Code | MJO |
| Date Received | 2020-02-27 |
| Model Number | NA |
| Catalog Number | MB3356 |
| Lot Number | 5249895 |
| 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 | 2020-02-27 |