MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-16 for JANUS 36-5640SP manufactured by Orthofix Medical Inc.
| Report Number | 2183449-2020-00002 |
| MDR Report Key | 9836151 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-16 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2018-02-20 |
| Date Added to Maude | 2020-03-16 |
| 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 | MRS. YOLANDA THOMPSON |
| Manufacturer Street | 3451 PLANO PARKWAY |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 9372291 |
| Manufacturer G1 | ORTHOFIX MEDICAL INC |
| Manufacturer Street | 3451 PLANO PARKWAY |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JANUS |
| Generic Name | MIDLINE FIXATION SCREW |
| Product Code | MNH |
| Date Received | 2020-03-16 |
| Model Number | 36-5640SP |
| Lot Number | 001 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX MEDICAL INC |
| Manufacturer Address | 3451 PLANO PARKWAY LEWISVILLE, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |