Question of the Month with Comment
MedSun: Newsletter #19, December 2007

Question:
Are other hospitals experiencing problems with head rests during neurosurgery cases? We have recently noted some "wobble" in the c-clamp after the pins are tightened. We have had two cases where patients received small lacerations due to movement of the pins. The manufacturer recommended that we buy another product at an additional price to "cure" the wobble.

Comment:
A search of the MedSun database reveals that 13 similar reports about problems with headrests or skull clamps have been received from 9 hospitals since August 2002. All involved Mayfield products. A skull fracture occurred in one report. In 10 of the reports a scalp laceration was sustained and sutures or staples were required in 5 of these 10 reports. See spreadsheet below for further details. These MedSun reports have been edited for clarity and in some instances have been summarized.:

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Model #/Other Device #: A1059
Event Description: On turning patient to prone position, one of the three skull pins slipped and cut the patient's skin. The clamp was reapplied in different area of skull.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Event Description: Partway through laminectomy, the head/neck very obviously changed position. Significant blood loss noted around pin sites and surgeon found large laceration at original pin site (single pin site) going through to skull and periosteum was removed. Another laceration, slightly less deep, was perpendicular to this. Lacerations were cleaned and sutured. Pin not found in original position and was fully retracted. This was a loaner clamp.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Event Description: Left sided pin was tightened to a standard torque of 60 lbs. As patient was being positioned, the pin slipped and a 1.5 cm laceration of the scalp resulted on the left temporal region. The resident sutured the laceration. This was a loaner set. C-clamp and pins for the Mayfield were replaced with another set.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp, Mayfield Headrest
Event Description: Patient was placed on a Mayfield headrest while on a stretcher. Patient was transferred onto OR bed and connected to the base of the Mayfield headrest. Once connected it would not stay locked on to the patient's head, and the patient suffered two 4-6 inch scalp lacerations. Large amount of blood loss. Patient put back on stretcher. Wounds were sutured.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Model #/Other Device #: A1059
Event Description: Doctor applied skull pins to patient's head in a Mayfield headrest. While applying pins, the doctor stated that "the tensioning device is not releasing." He immediately pulled the skull pin out of the patient's head and ordered a stat skull CT. CT revealed a skull fracture at pin site.

Manufacturer: Integra LifeSciences Corporation
Device: Type Skull clamp
Event Description: Patient's head was placed on skull pins. After they tightened the device, the skull clamp slipped from the lock position to unlock which caused a tear on the patient's head. Fracture stable.

Manufacturer: Integra LifeSciences Corporation
Device: Type Skull Clamp
Model #/Other Device #: A1114
Event Description: After case patient was undraped and it was noted that the 3 pin headrest had slipped causing a 1 1/2 inch cut in the patient's scalp that required staples to close.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull clamp
Model #/Other Device #: A1059
Event Description: The patient's head slipped out of pins due to Mayfield locking system failure. Patient's scalp torn out 5 or 6 cm. Physician stapled scalp.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull clamp
Event Description: Pins slipped after secured to patient's head. Pt sustained a laceration to the head.

Manufacturer: Cardinal Health Medical Products and Services
Device Type: Head Holder
Event Description: When putting patient's head in Mayfield, the swivel adapter did not hold. Surgeon supported the head until adapter was changed. At the end of the case, base unit slipped about 1/2 inch. No injury to patient. The washers have been slipping on these devices and the company representative has tried replacing these, but they continue to slip.

Manufacturer: Cardinal Health Medical Products
Device Type: Head Holder
Model #/Other Device #: M1570
Event Description: The patient was positioned in the Mayfield head rest. After start of case, anesthesia noted that the patient's orbits were resting on metal. The physician broke scrub and repositioned the head.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull clamp
Model #/Other Device #: A2000
Event Description: Patient with C-4 complete injury in Operating Room for cervical stabilization. Mayfield skull clamp used. Just prior to incision, patient's head noted to drop slightly, head was then supported. The locking mechanism, the part that rotates to secure position, had separated from the stationary part of the clamp. Patient neurologically at baseline

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Model #/Other Device #: A1059
Event Description: Patient positioned for neurosurgical procedure using Mayfield skull clamp. Clamp positioned and locked into place with a torque setting of 60 lbs. When surgical drapes were removed after procedure, 1 cm laceration noted on the patient's scalp. Surgeon noted torque gauge read 40 lbs. when laceration discovered. Wound closed with 3-0 vicryl.


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