RALTON-HALL LAMINECTOMY FRAME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-28 for RALTON-HALL LAMINECTOMY FRAME manufactured by Imperial Surgical Ltd..

Event Text Entries

[20769850] A patient moived forward about 5 inches while supported by a laminectomy frame and horseshoe headrest. This resulted in the headrest pressing against the patient's check bones for approx. Ten minutes. The patient was readjusstedx and placed in a slight reverse trendelenburg position. Upon awakening, the patient reported a loss of vision in the right eye. An ophthalmology consult was obtined. The most likely cause of her condition is retrobulbar ischemia, but tests for this have been inconclusive. The exact cause of her vision loss remains unexplained. The front halves of the fram were reported to have spread apart at some time during the procedure. Testing confirmed that the locking thumbscrews do not secure the movable posts adequately. Two of the thumbscrews were bent. The patient's excessive weight plus the poorly locked screws contributed to her slip forwardinvalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: expected wear/deterioration, material degradation/deterioration, patient's condition - predisposed event, unanticipated adverse reaction - long term. Conclusion: device failure occurred and was related to event, device evaluated and alleged failure could not be duplicated, user error contributed to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device repaired and put back in service, device use continued with restrictions/limitations, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5228
• MDR Report Key: 5228
• Date Received: 1993-04-28
• Date of Report: 1993-03-24
• Date of Event: 1993-03-02
• Date Facility Aware: 1993-03-02
• Report Date: 1993-03-24
• Date Reported to Mfgr: 1993-03-24
• Date Added to Maude: 1993-07-01
• Event Key: 0
• Report Source Code: User Facility 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: RALTON-HALL LAMINECTOMY FRAME
• Product Code: HPA
• Date Received: 1993-04-28
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4929
• Manufacturer: IMPERIAL SURGICAL LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-04-28