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

Catalog Number A1059

Device Problem Detachment Of Device Component (1104)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); Cognitive Changes (2551)

Event Date 03/29/2016

Event Type  Injury  

Event Description

A voluntary medwatch report was filed on 06 apr 2016 by a health professional (director, patient safety) at a user facility for an a1059 mayfield skull clamp.It was received by integra lifesciences on 18 may 2016 via postal mail.(b)(4).On (b)(6) 2016, the patient was positioned supine in mayfield 360 and 3 head points.The patient was secured to the table.Upon localization of tumor with navigation, it was discovered that tumor could not be accessed with the current navigational coordinates.When attending surgeon attempted to create a larger access point by enlarging the existing craniectomy, it was noted that the perforator caused trauma and bleeding.Neuromonitoring reported neurological changes when this had occurred.After hemostasis was achieved, the attending neurosurgeon consulted with neuromonitoring and it was noted that there were no improvements in neurological changes.The procedure was continued as planned.The patient's bed position was changed frequently throughout the procedure for better tumor access.After wound closure, the draping was removed and it was noted that the body had shifted on the table.Upon further patient assessment it was noted that one of the right sided headpins had become disengaged from the skull and allowed for a shifting of the head onto the support stem for the navigation system.The mayfield was removed immediately by attending and patient's right cheek had a dime sized indent with redness.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 19 jul 2016.The product was not returned for evaluation.A review of the device history records has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications.No manufacturing or design related trend has been identified.Conclusion: the device was not released for evaluation therefore the root cause to the end users experience could not be determined.If additional information is obtained, or the sample is returned, this investigation will be reopened.

• 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 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5716876
• MDR Text Key: 47119298
• Report Number: 3004608878-2016-00145
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2013
• 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
• Treatment: DRILL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 109