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

Catalog Number A1059

Device Problem Unstable (1667)

Patient Problem Laceration(s) (1946)

Event Date 11/03/2023

Event Type  Injury  

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

A facility reported that the rocker arm of the mayfield modified skull clamp (a1059) opened during the operation and the pin on the opposite site caused a deep wound that had to be stitched.Additional information was subsequently provided and translated from a regulatory report as follows: "after the mayfield clamp was applied as part of an operation on november 3rd, 2023, it was attached to the end joint which the head tilt is adjusted, is initially loosened slightly twice, in the sense that despite the closure at this joint, there was slight mobility.As part of another, slight rearrangement pulling on the mayfield then caused rotation over this joint again, causing the head to become a tearing of the skin and with a lack of pressure via the clamp leads to a complete loosening of the skin clamp came.".

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 the mayfield 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 - investigation of the returned unit showed that the pivot lock was loose, needed adjustment, had minimal play, and there was a buildup of residue.To resolve the issues, the internal parts were replaced to adjust the unit according to the manufacturer's specifications and to clean the pivot lock assembly.General maintenance and cleaning were performed, and after assembly was completed, the skull clamp was subjected to a successful functional test.Root cause - complaint is confirmed via inspection of the unit.Probable root causes include routine use and wear or lack of proper maintenance.Additionally, improper, or suboptimal placement of the skull clamp on the patient can contribute to movement or slippage of the patient and clamp during surgery.No corrective action has been initiated for the same or similar issue.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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: 18239203
• MDR Text Key: 329389767
• Report Number: 3004608878-2023-00218
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 122049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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: 84 YR