MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2010-09-29 for 5873 COUPLER ASSEMBLY FOR MAYFIELD HEADSET manufactured by Mizuho Orthopedic Systems, Inc..
[18241392]
During surgery, the knob that tightens the mayfield clamp to the jackson table attachment broke and the patient's head fell. The resident held the head in position while they closed and the patient was transferred to a new bed and a new attachment was placed and the surgery was completed. No injury occurred, but the surgery was prolonged by 1. 5 hours.
Patient Sequence No: 1, Text Type: D, B5
[18284065]
We currently are unable to determine the root cause of the failure as the failed component has not been returned for evaluation. A request to the distributor in (b)(4) for the return of the failed component has been issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2010-00012 |
| MDR Report Key | 1870330 |
| Report Source | 01,05,06,08 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-09-09 |
| Date Mfgr Received | 2010-09-14 |
| Date Added to Maude | 2011-03-31 |
| 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 AVE. |
| 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 AVE. |
| 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 | 5873 COUPLER ASSEMBLY FOR MAYFIELD HEADSET |
| Generic Name | OPERATING ROOM TABLE ACCESSORY |
| Product Code | JEB |
| Date Received | 2010-09-29 |
| Model Number | 5873 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-29 |