MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number A2114

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 01/26/2017

Event Type  Injury  

Event Description

The patient had a craniotomy and after the procedure, there was a laceration on the patient¿s head.Additional information has been requested.

Manufacturer Narrative

Additional information received on 06mar2016 with the following: on (b)(6) 2017, a (b)(6) female patient had an underlying medical condition of brain tumor.The patient was positioned supine for the surgery and was not repositioned at any time during the surgery.The surgery was not performed with a stereotaxy device.Integra adult skull pins (product id and lot number unknown) were used.The pins are not available to be returned for evaluation.The customer stated "normal" pounds of pressure was applied on the skull clamp.The laceration was noted at the end of the case; how the laceration was created was unknown.The laceration was approximately 1¿, irrigated with bacitracin irrigation and stapled closed then dressed.Integra has completed their internal investigation on 03/07/2017.The investigation included: a 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.No manufacturing or design related trend has been identified.Post market information will continue to be monitored.Conclusion: in summary - the device was not released for evaluation therefore the root cause to the end users experience could not be determined.Due to the nature of this reported failure the mayfield patient positioning for success chart has been provided in the below link as a refresher tool.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6348991
• MDR Text Key: 67964066
• Report Number: 3004608878-2017-00050
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K090506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• 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
• Patient Age: 65 YR