MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-21 for LEVO ARM 7887-050 manufactured by Mizuho Orthopedic Systems, Inc..
[183889955]
The levo arm was being positioned preoperatively and full movement and function of the arm was not available. The ball joint articulation point immediately posterior to the release button and handle was not moving freely. The device was returned to the manufacturer for evaluation. Evidence of fluid ingress and corrosion was found failures with a potential to cause unexpected motion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2020-00009 |
| MDR Report Key | 9739065 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2019-03-14 |
| Date Added to Maude | 2020-02-21 |
| 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 | ANNE LEBLANC |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4291500233 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2921578-10/16/2019-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVO ARM |
| Generic Name | HEAD/NECK PROCDURE POSITIONER |
| Product Code | JEA |
| Date Received | 2020-02-21 |
| Model Number | 7887-050 |
| Catalog Number | 7887-050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |