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

Catalog Number A1059

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/14/2019

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

A sales representative reported on behalf of the customer of an unspecified injury on a child patient with an a1059 mayfield modified skull clamp.The incident occurred on (b)(6) 2019.Additional information has been requested.

Manufacturer Narrative

The unit tested according to the manufacturer´s specifications.Some small parts will be replaced according to preventive maintenance.The device was manufactured in 2009.This device exceeded its expected life of 7 years.Evaluation was unable to conclusively verify the customer's information as valid since no failure was found.Root cause was unknown however, the most probable root causes for laceration and slippages are: incorrectly assembled device.Improperly tested/inspected device.Improper technique used during procedure.Off-label use of device during procedure (user error).Device used with incorrect/unauthorized devices/accessories for procedure.

Event Description

N/a.

• 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
• MDR Report Key: 8658239
• MDR Text Key: 146646688
• Report Number: 3004608878-2019-00125
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1