MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Model Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: evaluation of the returned unit found no device deficiencies that would have contributed to the reported complaint.Repairs team could not duplicate slippage and found that when the clamp was properly positioned and put under pressure the unit will function properly.Unrelated to the reported complaint, the lock had both rotational and lateral movement and a residue buildup was present.Upon disassembly, it was noted that the index knob and the lock will need new components added to replace worn internal parts; unit was machined to have heli-coils added to large starburst threads.Unit is 2 years old and requires, at least, preventative maintenance.New components were added to replace worn internal parts and general maintenance and cleaning performed.Further investigation by quality engineering confirms the findings of the s&r report.Unit showed signs of wear and there was slight movement observed in the lock.Root cause: probable root cause is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

This is 1 of 2 reports linked to mfg report number 3004608878-2022-00285: a facility reported that 1 of 2 mayfield modified skull clamps (a1059) caused harm to a patient resulting in a 3 inch laceration of the scalp.The mayfield was not holding the pounds of pressure after being put to 60lbs, and the patient's head did slip while fixated.The mayfield devices were changed out after that and cleaned, but the facility is not sure which one was not holding.As a result, both devices have been returned for evaluation.Additional information received indicates the following: the patient was initially positioned prone for posterior cervical procedure.No repositioning.The patient's head was fixed for about 10-15 mins before it was noticed it wasn't holding the pounds of pressure.Type of surgery was posterior cervical: there was no delay.Staples were applied to laceration before the surgical procedure started.Mayfield headrest was switched out for a new one.Surgery proceeded.Patient outcome/current condition is stable.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16040391
• MDR Text Key: 306068009
• Report Number: 3004608878-2022-00284
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71