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 2020-03-13 for ROI-A WIDE IMPLANT PXL : 27X36 H 12MM 14? IR5241P manufactured by Ldr Medical.
[183329085]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183329086]
It was reported that during the procedure the anchoring plate was difficult to insert and when the surgeon attempted to remove the plate, it would not dislodge from the cage. The cage and plate were removed and alternates were used to complete the case without reported patient impacts. This is report two of two for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2020-00024 |
| MDR Report Key | 9829198 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-13 |
| 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 46582 |
| Manufacturer Country | FR |
| Manufacturer Postal | 46582 |
| 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-A WIDE IMPLANT PXL : 27X36 H 12MM 14? |
| Generic Name | ROI-A ALIF CAGE SYSTEM |
| Product Code | MAX |
| Date Received | 2020-03-13 |
| Model Number | NA |
| Catalog Number | IR5241P |
| Lot Number | 18-250329 |
| 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 | 2020-03-13 |