MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD HEAD HOLDER; SKULLCLAMPS AND HEADREST SYSTEMS

Catalog Number XXX-HEADREST

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported information.

Event Description

(b)(4) received from fda on 25may2017.It was reported that on (b)(6) 2017, a (b)(6) white patient was positioned for neurosurgery with his head secured in the mayfield head holder.After positioning had been completed and the pins were locked, the lock knob on the skull clamp was observed to turn to unlocked on its own.This cause the pins to slip and resulted in a 3-inch laceration that required stapes.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on june 28, 2017.Results: evaluation of returned device; the device was not released for evaluation.Dhr review; cannot be performed at this time as the lot number was not provided nor was the product sent in for inspection.This review will take place once either or has been provided.Complaints history; no manufacturing or design related trend has been identified.Post market information will continue to be monitored.Conclusion: root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.

• Brand Name: MAYFIELD HEAD HOLDER
• Type of Device: SKULLCLAMPS 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6624031
• MDR Text Key: 77210130
• Report Number: 3004608878-2017-00183
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HEADREST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR