MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-04 for ROI-C IMPLANT, UNKNOWN SIZE manufactured by Ldr Medical.
[187556779]
Common device name is similar to roi-c titanium-coated implant system 510k is similar to k151934 the device information is unknown, so the specific common device name and 510(k) number cannot be determined. 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.
Patient Sequence No: 1, Text Type: N, H10
[187556780]
It was reported that a cage broke intra-op. Unknown surgical intervention was performed during the surgery. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2020-00015 |
| MDR Report Key | 9667874 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-10-03 |
| 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 | ROI-C IMPLANT, UNKNOWN SIZE |
| Generic Name | SEE H10 |
| Product Code | OVE |
| Date Received | 2020-02-04 |
| 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 | 2020-02-04 |