MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for NEON3 CS 3938-06 manufactured by Ulrich Gmbh & Co. Kg.
[186822150]
A revision was done 6 march as a result of screws backing out. During the revision when they were trying to replace a rod the rod reducer got stuck on the rod. The surgeon ended up removing the entire construct. Report 5 of 5.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005823819-2020-00010 |
| MDR Report Key | 9875674 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-06 |
| Date Facility Aware | 2020-03-06 |
| Report Date | 2020-03-24 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEON3 |
| Generic Name | ROD REDUCTION INSTRUMENT |
| Product Code | KWP |
| Date Received | 2020-03-24 |
| Model Number | CS 3938-06 |
| Catalog Number | CS 3938-06 |
| Lot Number | NI |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULRICH GMBH & CO. KG |
| Manufacturer Address | BUCHBRUNNENWEG 12 ULM, 89081 GM 89081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-24 |