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

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - investigation of the returned unit was unable to duplicate slippage when all components were put together.However, the unit had a sticking lock, and the index knob was the older style.Also, the ratchet extension is not moving smoothly through the base casting.Since the unit is over 10 years old (manufactured in 2008), we can no longer service it.Consequently, the unit will not be repaired and will be returned to the customer after the quality engineering investigation.Root cause - the complaint is not confirmed.The probable root cause of the reported complaint is improper or suboptimal position of the skull clamp on the patient since the evaluation found no device deficiencies that would have contributed to the reported complaint.The unit is 15 years old and exceeds integra's 10-year service life and cannot be serviced for repairs any longer.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

This is 1 of 4 reports linked to mfg report numbers: 3004608878-2023-00245, 3004608878-2023-00244, 3004608878-2023-00243.A facility reported that during a posterior cervical laminectomy with laminoplasty procedure, the mayfield modified skull clamp (a1059) slipped, resulting in a 1-2cm laceration on the right side of the patient's head.No intervention was performed.However, the patient had to be transferred back to litter until another mayfield could be obtained resulting in surgical delay of approximately 2 hours while the patient was intubated.The patient was discharged the following day without further issue.Patient is caucasian, 'not hispanic or latino.'.

• 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: 18430863
• MDR Text Key: 331820961
• Report Number: 3004608878-2023-00242
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female