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 5855 ORTHOPEDIC TABLE manufactured by Mizuho Osi.
[20952230]
During a repair of a 5855 orthopedic table, the technician found the table spar connecting the table top had become cracked and was separating from the spar mount assembly.
Patient Sequence No: 1, Text Type: D, B5
[21224827]
During a repair of a (b)(4) orthopedic table top, the technician found the table top had become cracked and separated from the spar mount assembly. We will notify upon completion of investigation ((b)(4) 2011).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00020 |
| MDR Report Key | 2243724 |
| Report Source | 06,07 |
| Date Received | 2011-07-29 |
| Date of Report | 2011-07-28 |
| Date of Event | 2011-07-13 |
| Date Mfgr Received | 2011-07-13 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2011-10-26 |
| 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 | 5855 ORTHOPEDIC TABLE |
| Generic Name | ORTHOPEDIC TABLE |
| Product Code | JEB |
| Date Received | 2011-07-29 |
| Returned To Mfg | 2011-07-13 |
| Model Number | 5855 |
| Catalog Number | 5855 |
| Device Availability | Y |
| Device Age | DA |
| 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 |