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 10/24/2023

Event Type  Injury  

Event Description

This is 1 of 2 reports linked to mfg report number 3004608878-2023-00247: medwatch report# 3000030000-2023-8004 was received with the following information: "mayfield skull clamp was placed on patient.The torque knob was tightened to 40lbs of force and the locking mechanism was locked.Patient was then placed prone and positioned using gel rolls.When the head was flexed by way of the head clamp, the locking mechanism failed.The pin slipped on the patient's head, causing a 2" scalp laceration.If the pin would have slipped completely, the head would not have been supported, risking a high cervical injury.The scalp laceration was sutured after we returned the patient in the supine position the hospital bed.We attached another clamp and manipulated the head in the same way, with the same result.The second head clamp was removed and the remainder of the procedure was done with the head on a cerebellar headrest.The two devices involved were sn [redacted number] and [redacted number], but it¿s unknown which device was used first or second.'' what was the original intended procedure? : elective chiari decompression.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

N/a.

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 - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.When the unit was properly positioned and put under pressure it did not move, and "slippage" could not be duplicated.Unrelated to the complaint issue, the lock had rotational and lateral movement, a residue buildup was present, and the 80lb torque knob is an older style that does not have a gas hole in the piston.New components will be added to replace worn internal parts along with general cleaning and maintenance performed.Root cause - the complaint is not confirmed.The probable root cause is improper or suboptimal positioning 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.At present, we consider this complaint to be closed.

• 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: 18432121
• MDR Text Key: 331868449
• Report Number: 3004608878-2023-00246
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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: 15 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White