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

Catalog Number A1059

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

A report was received that the a1059 mayfield modified skull clamp slipped causing injury to the patient.During the case the device dropped the patient's head out of the headpiece causing the patient injury.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 13 jul 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the complaint was not confirmed and no issues were observed.With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have slipped.General maintenance and cleaning required.The dhr review has been deemed satisfactory.This device was manufactured on 30-jun-2009 and a review of dhrs containing lot code 094 showed that the lot passed the required inspection points without mrrs or variances.No manufacturing or design related trend has been identified.Conclusion: in summary we are unable to confirm or duplicate the end users experience.The returned unit passed all functional testing requirements, however general maintenance is required as this device was manufactured in 2009 last serviced in 2014.

• 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: 5707354
• MDR Text Key: 46858480
• Report Number: 3004608878-2016-00143
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2009
• 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 Outcome(s): Other; Required Intervention