MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-07 for COFLEX INTERLAMINAR TECHNOLOGY manufactured by Paradigm Spine Gmbh.
[173929848]
In (b)(6) 2019, the patient had two coflex implants implanted. He had complications, including fracture and a bone fragment floating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005725110-2019-00002 |
| MDR Report Key | 9556772 |
| Report Source | OTHER |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date Mfgr Received | 2019-12-09 |
| Date Added to Maude | 2020-01-07 |
| 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. ALBERTO JURADO |
| Manufacturer Street | EISENBAHNSTRASSE 84 |
| Manufacturer City | WURMLINGEN, 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78573 |
| Manufacturer G1 | PARADIGM SPINE GMBH |
| Manufacturer Street | EISENBAHNSTRA[?]E 84 |
| Manufacturer City | WURMLINGEN, 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COFLEX INTERLAMINAR TECHNOLOGY |
| Generic Name | PROSTHESIS, SPINOUS PROCESS SPACER |
| Product Code | NQO |
| Date Received | 2020-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARADIGM SPINE GMBH |
| Manufacturer Address | EISENBAHNSTRASSE 84 WURMLINGEN, 78573 GM 78573 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-07 |