MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-03-27 for IMPLANT ROI-C LORDOSE MC1444P manufactured by Ldr Medical.
[187559374]
Exemption number (b)(4) - ldr spine usa, inc. (importer) is submitting the report on behalf of ldr medical (manufacturer). (b)(4). Other: distributor (b)(4). Follow-up with cdrh dt support team on (b)(6) 2020 determined this submission could not be located, so it is being resubmitted. The correspondance is attach in an email to this report.
Patient Sequence No: 1, Text Type: N, H10
[187559375]
At final fluoro, marker appeared too posterior. Surgeon removed cage and plates and completed case with a competitor construct. Patient woke with paraplegia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004903783-2017-00009 |
| MDR Report Key | 9888934 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-30 |
| Date of Event | 2016-11-30 |
| Date Facility Aware | 2017-02-03 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-27 |
| 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. ADRIANA RUSSEL |
| Manufacturer Street | 13785 RESEARCH BLVD. #200 |
| Manufacturer City | AUSTIN TX 78750 |
| Manufacturer Country | US |
| Manufacturer Postal | 78750 |
| Manufacturer Phone | 5123443333 |
| Manufacturer G1 | LDR MEDICAL REG # 3004788213 |
| Manufacturer Street | SEE H10 SEE H10 |
| Manufacturer City | SAINTE-SAVINE 10300 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 10300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANT ROI-C LORDOSE |
| Generic Name | LDR SPINE ROI-C CERVICAL CAGE SYSTEM |
| Product Code | OVE |
| Date Received | 2020-03-27 |
| Model Number | NA |
| Catalog Number | MC1444P |
| Lot Number | 45841 |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LDR MEDICAL |
| Manufacturer Address | SEE H10 SEE H10 SAINTE-SAVINE 10300 FR 10300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2020-03-27 |