UNKNOWN MAYFIELD SKULL CLAMP
Received Jul 21, 2026
Report 3004608878-2026-00076 · MDR key 25896622
Device
Generic name
Mayfield
Manufacturer
Integra Lifesciences Corporation Oh/usaCatalog number
XXX-MAYFIELD SKULL CLAMP
Product problems
- Device Slipped
Patient
Not reported
- Laceration(s)
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL SUBMITTED.
Description of Event or Problem
A FACILITY REPORTED THAT DURING A NEUROSURGICAL PROCEDURE, A MAYFIELD SKULL CLAMP (EXACT PRODUCT CODE/SERIAL NUMBER UNKNOWN) SLIPPED WHILST IN USE AND RESULTED IN A 5CM SCALP LACERATION TO THE PATIENT. MUCH INFORMATION ABOUT THE EVENT IS STILL UNKNOWN, INCLUDING THE DATE OF THE EVENT (APPROXIMATELY 2 MONTHS AGO) AND THE PRODUCT USED (IT IS ASSUMED TO BE A MAYFIELD 2 SKULL CLAMP BUT THIS IS UNABLE TO BE CONFIRMED AT THIS TIME). WE ARE ATTEMPTING TO DETERMINE THE PRODUCT USED AND IF SUCCESSFUL IT WILL BE RETURNED TO INTEGRA'S AUSTRALIA FOR ASSESSMENT.