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 2020-02-28 for ASPIRON ACP SYSTEM NC3518VD manufactured by U&i Corporation.
| Report Number | 9617297-2020-00003 |
| MDR Report Key | 9767877 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2014-08-22 |
| Date Added to Maude | 2020-02-28 |
| 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 | MR. WOODY JANG |
| Manufacturer Street | 20, SANDAN-RO 76BEON-GIL |
| Manufacturer City | UIJEONGBU, GYEONGGI-DO 11781 |
| Manufacturer Country | KS |
| Manufacturer Postal | 11781 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIRON ACP SYSTEM |
| Generic Name | SPINAL INTERVERTABRAL BODY FIXATION ORTHOSIS (KWQ) |
| Product Code | KWQ |
| Date Received | 2020-02-28 |
| Catalog Number | NC3518VD |
| Lot Number | 14G265 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | U&I CORPORATION |
| Manufacturer Address | 20, SANDAN-RO 76BEON-GIL UIJEONGBU, GYEONGGI-DO 11781 KS 11781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |