MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-24 for EASY SPINE SCREW, UNKNOWN manufactured by Ldr Medical.
[187556338]
Common device name: easy spine system or ldr spine usa spine tune, tl spinal system, ldr spine usa easy spine, posterior spinal system, ldr spine usa mc implant s... 510(k) number: k123134 or k121103. 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. Reference reports 3004788213-2020-00029 to 3004788213-2020-00034.
Patient Sequence No: 1, Text Type: N, H10
[187556339]
It was reported that a patient underwent a revision surgery to remove an easy spine construct for an unknown reason. There was no further surgical or patient information provided. This is report three of six for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2020-00031 |
| MDR Report Key | 9876089 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-24 |
| 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 | EASY SPINE SCREW, UNKNOWN |
| Generic Name | SEE H10 |
| Product Code | NKB |
| Date Received | 2020-03-24 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-24 |