MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/19/2017

Event Type  malfunction  

Event Description

The a3059 locking rocker arm moved during surgery.The head frame was applied and the stealth registered.The patient was draped and surgery began.While raising the scalp flap, nothing strenuous like turning a bone flap, it appeared that there was movement of the head.The stealth was checked and it was off.They checked under the drapes to see if the head had slipped in the pins but the skin was okay and there were no scalp lacerations.The stealth however was off.Surgery was completed without being able to use the neuro-navigation but at the end, the skin would not close due to too much tension.Partial sutures were placed, kept the head sterile, detached the mayfield, and the head was placed on a headboard.The closure was finished with everything kept sterile.It appeared that the locking mechanism on the pivot moved in the beginning of the case even though it had been tightened down.There were no pin site migrations and the pins were in tightly.

Manufacturer Narrative

Integra has completed their internal investigation on october 31, 2017.Failure analysis : the device in question was not released for review; should the product be returned a failure analysis and/or root cause will review will be performed at that time.Device history record: the device in question was not released for review or was the lot number provided.A dhr review will be performed when either has been submitted.Trend analysis: a query in the complaint system from 10/10/2015 to 10/10/2017 for this reported failure using key words "slipped, head, positioner " for product id a1114 shows 2 complaints including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Root cause is not determined at this time, because the product has not been returned for evaluation.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7009743
• MDR Text Key: 92774186
• Report Number: 3004608878-2017-00308
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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