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

Catalog Number A1059

Device Problems Device Slipped (1584); Material Torqued (2980)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Event Description

The a1059 mayfield modified skull clamp slipped.The neurosurgeon stated that the skull clamp slipped on the single pin, torque knob side after the device was applied to the patient.There was no patient injury, no revision or medical intervention required and no delay in surgery due to the product problem.Additional information was requested.

Manufacturer Narrative

Integra has completed their internal investigation on 12/19/2016.The product was not returned for evaluation.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.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 as a refresher tool.

Manufacturer Narrative

Additional information was received on 01/09/2017: the incident took place on (b)(6) 2016 while a (b)(6) female patient was undergoing a retromastoid craniectomy resection elst for an acoustic neuroma.The patient was initially positioned lateral with a bean bag and she did not need to be repositioned.A stereotaxy device was not in use.When the slip occurred the team obtained a new skull clamp.Disposable adult skull pins were in use.The fellow discovered single pin was slipping prior to putting on patient and the skull clamp was taken out of service.

• 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: 6147543
• MDR Text Key: 62315029
• Report Number: 3004608878-2016-00335
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• 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
• Treatment: SKULL PINS
• Patient Age: 36 YR