MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD 2 SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number A3509

Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Laceration(s) (1946); Cognitive Changes (2551)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

An elderly patient presented to the emergency department via ems from an outside hospital with headache and altered mental status.The patient was intubated on transfer to this facility.The patient's wife reported he experienced a sudden onset headache at home.They were preparing to go to the local emergency department when his symptoms became so severe that he asked for an ambulance.The patient has a history of hypertension on no medication.A ct was performed and the patient was found to have cerebellar iph with ivh and hydrocephalus.The following day, the patient underwent suboccipital craniectomy, expansile duraplasty with hematoma evacuation.The patient's head was placed in a mayfield skull clamp in locked position.The patient was turned from supine to prone.The clamping mechanism was not working appropriately and a slight slip of the mayfield pin resulting in a small scalp laceration (2cm).This was irrigated thoroughly and stapled to approximate the scalp without any further issues.The procedure was completed and the patient remains critically ill in the hospital.The mayfield had been applied correctly.The surgeon reported the rocker pin arm was locked but the rocker had loosened after positioning the patient from supine to prone.It remained loose after trying to reapply the same clamp.This was addressed by the surgeon who removed the mayfield clamp and applied a new one which worked without issue.The small laceration was then cleaned and stapled.No adverse sequela was noted.The defective clamp was removed from service and the manufacturer was notified.

• Brand Name: MAYFIELD 2 SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 4900 charlemar drive; building a; cincinnati OH 45227
• MDR Report Key: 7406861
• MDR Text Key: 104730963
• Report Number: 7406861
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: A3509
• Device Catalogue Number: A3509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 100