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

Catalog Number A1059

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on 11 nov 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 - no issues observed.Unit cleaned per protocol.With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement when unit is not under pressure, 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 device in question was manufactured on 31-dec-2010.No manufacturing or design related trend has been identified.Conclusion: in summary: after further information was provided by this customer on this case it appears that this is simply a service request.As such this device passed all functional testing requirements but general maintenance is required as it was manufactured in 2010 and last serviced in 2014.Lastly this customer did mention doro skull pins.Per the ifu with respect to ¿non-mayfield branded products used with mayfield products - we caution that we have only validated mayfield products used in conjunction with the mayfield product line, and as a result, cannot advise you whether suppliers¿ products would work properly with the mayfield line of products.".

Event Description

The a1059 mayfield modified skull clamp was experiencing a problem.On (b)(6) 2016 it was reported that the patient had a skull fracture post operation.On (b)(6) 2016, after further inquiry and investigation of the reported incident, by the ils sales specialist, it was reported that there was no patient injury and the customer would like the skull clamp evaluated.Additional information on 21 oct 2016 reported that the customer had used doro brand skull pins (and not mayfield brand).On (b)(6) 2016 it was reported there was no patient injury and the skull clamp was being sent in to have the tension checked.

• 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: 6117853
• MDR Text Key: 60634168
• Report Number: 3004608878-2016-00324
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• 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
• Report Date: 10/04/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2010
• 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: DORO BRAND SKULL PINS