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

Catalog Number A1059

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 01/20/2017

Event Type  Injury  

Event Description

It was reported that there was a need for re-positioning of the device while attached to the patient.The nurse anesthetist (crna) notified the surgeon during the procedure that patient's face was lying against a bar of the securing head holder device.The surgeon broke scrub to evaluate.The patient's forehead appeared to be against the bar.The surgeon repositioned and re-secured the patient's head with the same mayfield pin-in head holder, and completed surgery without further issues.At the end of the procedure when the pin-in head holder was removed, the surgeon noted and subsequently closed with staples a laceration on the patient's left posterior parietal scalp.Additional information has been requested.

Manufacturer Narrative

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.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 as a refresher tool.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6332870
• MDR Text Key: 67515486
• Report Number: 3004608878-2017-00048
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• 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
• Treatment: SKULL PINS
• Patient Outcome(s): Required Intervention