MAYFIELD A-1059 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-26 for MAYFIELD A-1059 N/A manufactured by Ohio Medical Instrument Co..

Event Text Entries

[20242193] A patient received a depressed skull fracture during application of a mayfield skull clamp. The surgeon was adjusting the force to 60 lbs. , when he noticed that the torque knob was spinning without an increase in force. There also appeared to be an obvious depression at the pin site in the left parietal area. The surgeon performed a craniotomy to check for the presence of skull fragments and bleeding. None was found and the surgery proceeded without further incident. The surgeon believes the patient's condition (hydrocephalus and a pineal tumor) caused an unusually thin skull. As a result, the force setting (60 lbs. ) was too great. Using a redeuced force (25 to 30 lbs. ) would have been more appropriate for the patient. The skull clamp was examined by clinical engineering and found to be in good condition. The reusable pins were also examined and there was evidence of damage to one pin tip, possibly the beginning of a fracture. The condition of the pins did not contribute to the event. Device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jul-92. Service provided by: user facility biomedical/bioengineering department. Service records 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, performance tests performed, visual examination. Results of evaluation: incorrect technique/procedure, patient's condition - predisposed event, unanticipated short term complication of procedure. Conclusion: no failure detected and product within specification, there was no device failure, user error caused event. Certainty of device as cause of or contributor to event: no. Corrective actions: user education provided, inserviced by manufacturer/distributor representative. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3233
• MDR Report Key: 3233
• Date Received: 1993-01-26
• Date of Event: 1992-09-14
• Date Facility Aware: 1992-09-14
• Date Reported to Mfgr: 1992-10-01
• Date Added to Maude: 1993-04-13
• 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

• Brand Name: MAYFIELD
• Generic Name: SKULL CLAMP
• Product Code: IPX
• Date Received: 1993-01-26
• Model Number: A-1059
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: 90018
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3017
• Manufacturer: OHIO MEDICAL INSTRUMENT CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-26