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

Catalog Number A3059

Device Problem Retraction Problem (1536)

Patient Problem Laceration(s) (1946)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A sales representative reported on behalf of the customer that on (b)(6) 2020, the torque knob of the a3059 mayfield composite series skull clamp retracted.The physician was pinning a female patient in her late thirties and alleged that after placement of the clamp, the pounds of pressure was between 3 and 4.At that point, the 80 pound (lb.) torque knob retracted and the pounds of pressure was between 2 and 3.The patient was in a prone position during the craniotomy procedure.There was laceration on both sides of the head down to the mid part of the patient's cheek bone from the skull pins.The physician held the patient¿s head until they could remove the clamp.There was surgery delay of 35 to 45 minutes.There was no patient adverse consequence due to the delay.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h4, h6, h10.Udi # (b)(4).No device or photos were received for evaluation therefore the failure analysis to identify root cause to the end user's experience could not be determined.The reported complaint was not confirmed.The device history record (dhr) review showed no abnormalities related to the reported failure.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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
• MDR Report Key: 10280202
• MDR Text Key: 202719909
• Report Number: 3004608878-2020-00192
• 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
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SKULL PINS