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

Catalog Number A3059

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An assistant nurse manager reported that a craniotomy procedure was planned for the patient on (b)(6) 2019 using the mayfield 2 system (a3059 mayfield composite series skull clamp and a3101 mayfield composite series base unit) along with three (3) reusable pins.The torque knob with the pin in place was on frontal position with the measurement of the pressure at 60 pounds.The pins were inserted in the bone but the surgeon was not comfortable on the skull clamp position and the pressure of the skull clamp.The torque knob was unscrewed and the pins pierced the skull bone.Additional information has been requested but no other clinical information has been provided.

Manufacturer Narrative

The device was not returned for evaluation.Failure analysis cannot be completed due to the lack of information received.A dhr review cannot be performed at this time as the serial number provided does not appear to be a valid integra number.The reported complaint was not confirmed.Root cause analysis cannot be completed at the moment.

Event Description

N/a.

• 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: 8354675
• MDR Text Key: 136729057
• Report Number: 3004608878-2019-00037
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• 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: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A3101 BASE UNIT; REUSABLE PINS