MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-05-14 for JACKSON TABLE SYSTEM 5803 manufactured by Mizuho Orthopedic Systems, Inc..
[20508139]
The case reportedly lasted more than 10 hours, patient sued orthopedic surgeon and anesthesiologist because of a brachial plexus neuropathy suffered during or after the surgery. No mdr was filed by the hospital according to hospital attorney. Also, no one is alleging any malfunction or non-performance of the jackson table. This call was the first notification we received of this event and our company is not named in the suit.
Patient Sequence No: 1, Text Type: D, B5
[20822411]
Device not evaluated, mdr issued due to patient related incident. According to hospital, device is not cause of injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2008-00013 |
| MDR Report Key | 1045991 |
| Report Source | 00 |
| Date Received | 2008-05-14 |
| Date of Report | 2008-05-13 |
| Date of Event | 2005-03-15 |
| Date Mfgr Received | 2008-04-14 |
| Date Added to Maude | 2008-05-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. 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 ORTHOPEDIC SYSTEMS, INC. |
| 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 | JACKSON TABLE SYSTEM |
| Generic Name | OPERATING ROOM TABLE, PRODUCT CODE: FWY |
| Product Code | FWY |
| Date Received | 2008-05-14 |
| Model Number | 5803 |
| Catalog Number | 5803 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1015039 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 945871234 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-14 |