MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-07 for STRYKER FRAME 124 * manufactured by Stryker Medical.
[298055]
Pt with traumatic cervical spine injury with a c3-4 subluxation was placed into cervical tong traction and placed onto a stryker frame. The pt was on their back on the frame. The top part of the frame was applied and all screws secured and double checked for tightness by two nurses. The pt was turned onto their abdomen when shortly thereafter the bottom screw at the head of the frame slipped and the frame fell downward. The pt was held in place by the tongs with some hyperextension. The nurse at the head of the bed secured the frame back into position, replaced the screw and the pt was turned onto their back. The pt remained neurologically stable throughout.
Patient Sequence No: 1, Text Type: D, B5
[306119]
Add'l info received from mfr 03/27/03: stryker medical's investigation into this report has been completed. The events described in the medical device report are not attributable to the device. Investigation revealed that the root cause of this problem was user error. The stryker service technician reported that he examined the unit and it was functioning properly. The service technician spoke with the medical center's director of engineering and the equipment technician. Both the director of engineering and equipment technician confirmed that the nurse that was using the unit did not secure the bottom screw at the head end of the frame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027195 |
| MDR Report Key | 437074 |
| Date Received | 2003-01-07 |
| Date of Report | 2003-01-07 |
| Date of Event | 2002-11-30 |
| Date Added to Maude | 2003-01-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER FRAME |
| Generic Name | SPINAL TURNING FRAME |
| Product Code | INY |
| Date Received | 2003-01-07 |
| Model Number | 124 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 426011 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | 6300 SO. SPRINKLE RD KALAMAZOO MI 490019799 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-01-07 |