MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-07-29 for 6850 PROFX manufactured by Mizuho Osi.
[2245810]
The glue holding the push rod on the profx spar failed an the foot end fitting broke off.
Patient Sequence No: 1, Text Type: D, B5
[9292180]
Initial investigation begun. Will advise upon completion ((b)(4) 2011).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00018 |
| MDR Report Key | 2243722 |
| Report Source | 06,07 |
| Date Received | 2011-07-29 |
| Date of Report | 2011-07-28 |
| Date of Event | 2011-06-11 |
| Date Added to Maude | 2012-06-15 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | MIZUHO OSI |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6850 PROFX |
| Generic Name | ORTHOPEDIC OPERATING ROOM TABLE |
| Product Code | JEB |
| Date Received | 2011-07-29 |
| Model Number | 6850 |
| Catalog Number | 6850 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO OSI |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-29 |