Summary of MedSun Reports Describing Adverse Events With Integra LifeSciences Corp.'s MAYFIELD Skull Clamp
MedSun: Newsletter #34, March 2009
Over the past 2 years, MedSun has received 12 adverse event reports associated with the Mayfield Skull Clamp device manufactured by Integra LifeSciences Corporation. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold the head and neck in a particular position during surgical procedures. The reports were submitted by 6 hospitals between February 13, 2007 and February 13, 2009. The most frequently reported device problem was:
• Unintended movement or slippage of the skull clamp or pins
None of the reports involved a patient death. The patient injuries listed below were reported in 9 of these 12 reports.
All 9 of the reports that listed patient age had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 8 reports involved female patients and a total of 4 reports involved male patients.
These MedSun reports contributed to FDA awareness of the device problems. FDA currently has this issue under review.
|Device||Device Identifiers||Event Description|
|Integra LifeSciences Corp. / MAYFIELD Headrest||Device identifiers unknown||Patient was placed on a Mayfield Headrest while on a stretcher. Patient was flipped onto OR bed and connected to the base of the Mayfield Headrest. Once connected it would not stay locked onto the patient's head, and the patient suffered two 4-6 inch lacerations to scalp. Large amount of blood poured onto floor and patient then had to be flipped back onto stretcher. Wounds were sutured.|
|Integra LifeSciences Corp. / MAYFIELD Modified Skull Clamp with Skull Pins||Device identifiers unknown||During the prep stage, the patient was placed in Mayfield head holder by the neurosurgical resident. Left sided pin was tightened to a torque of 60 lbs. Patient was being positioned by the resident and the physician assistant, the pin slipped and a 1.5 cm laceration of the scalp resulted on the left temporal region. The resident sutured the laceration, and notifications were sent out. C-clamp and pins for the Mayfield were replaced with another set. The c-clamp and pins were segregated. This was a loaner set in which the torque screws were located on the two pin holders as well as on the left side of the c-clamp. The neurological Director requested an extra staff member be available at the head of the table with the Anesthesiologist to prevent this event from recurring.|
|Integra LifeSciences Corp. / MAYFIELD Head Clamp||Device identifiers unknown||Partway through a laminectomy procedure, while holding the hand drill to make entrance holes for screws in posterior cervical spine, there was a "clunk" and the head/neck very obviously changed position. Shortly after, Anesthesia informed of new and significant blood loss from area of pins. 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 fully retracted. (Of note, this was a loaner clamp following the recent problem with our own Mayfield skull clamp.)|
|Integra LifeSciences Corp. / MAYFIELD||A-1059||Head clamp holds three skull pins for stabilizing the head during neurosurgical procedures. On turning patient to prone position, one pin slipped and cut the patient's skin. The clamp was reapplied in different area of skull and patient was connected to bed attachment for securing patient head in proper position for surgery.|
|Integra LifeSciences Corp. / MAYFIELD||40A1059||Skull clamp placed by a resident intra-operatively caused a laceration of the skull.|
|Integra LifeSciences Corp. / MAYFIELD Skull Clamp||A-1059|| Surgeon placed skull clamp on patient's head. Patient then turned prone in preparation for surgery on cervical spine. Clamp was firmly attached to Mayfield base support which is firmly attached to the OR table. While head was being repositioned by surgeon the swivel lock appeared to become unlocked and patient's head fell downward with the bridge of his nose striking the crossbar of the skull clamp. This injury was superficial. The surgeon once again repositioned and re-secured the head but then the head was "spontaneously ejected" from the skull clamp, resulting in a deep 5cm laceration above the right ear. This required closure with skin staples.|
Manufacturer response for Skull clamp/head support (per reporting facility):
The manufacturer acknowledged the device's inherent instability. They supplied us with a loaner clamp while they evaluate ours. They provided me with the instructions for use upon request. The IFU does state that "The direction of the single pin should point directly through the center point created by the centerlines of the patient's head with the pins on the two-pin side of the skull clamp being equidistant to single-pin line of direction to obtain the highest degree of stability."
|Integra LifeSciences Corp. / MAYFIELD||Models 1059 and A1072|| A three cm laceration was noted on the patient’s left side of the scalp as the patient was being positioned for posterior cervical laminectomy. The Mayfield skull clamp (Integra 1059) was being applied by the Doctor with Mayfield disposable skull pins in place (Integra A1072). Packaging was discarded; lot #, expiration date unknown. |
Laceration closed. New skull pins applied. Another Mayfield Skull Clamp used without incident. Original Mayfield Skull Clamp removed from the OR, to be sent to company for evaluation with the permission of Risk Management.
|Integra LifeSciences Corp. / MAYFIELD||40A1059|| The patient was scheduled for posterior cervical fusion.|
At the end of the procedure, it was noted that the pin sites on the head had shifted. The left posterior pin site had a one inch tear. The laceration was sutured by the surgeon.
|Integra LifeSciences Corp. / MAYFIELD||Device identifiers unknown||The patient was being positioned on OR table for anterior cervical fusion with horseshoe head holder. Surgeon felt that head holder moved as pressure was being applied. Circulating nursing did not observe any movement. No patient harm per surgeon. Device sent to manufacturer for evaluation.|
|Integra LifeSciences Corp. / MAYFIELD||A-1059||Case was a craniotomy. Intraoperatively after application of Mayfield skull clamp it slipped out of position from the patient's head. Patient not injured and the appliance was replaced with another Mayfield skull clamp.|
|Integra LifeSciences Corp. / Integra MAYFIELD Skull Clamp||40A1059||After application of the head holder, it slipped twice causing two lacerations. The lacerations were stapled.|
|Integra LifeSciences Corp. /Mayfield Head Rest or Head Clamp||A-1059||Patient was undergoing AVM for Chiari Malformation when intraoperatively the resident heard and then saw pins on Mayfield pop out of patient's head. Resident secured head and new Mayfield head rest was brought to OR. The new Mayfield was positioned, patient assessed and the new Mayfield remained in place for remainder of surgery. Outcome is still open to sequelae due to intraoperative surgery halt.|