MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A2000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the rocker arm on mayfield skull clamp (a2000) is loose when the system is unlocked.The torque screw was also loose.There was no patient injury as the issue was discovered before a craniotomy procedure for tumor ablation.The patient was prepped for surgery and there was a delay for five (5) minutes as another clamp was taken to perform the surgery.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.Mayfield skull clamp (a2000) was returned for evaluation.The reported complaint was confirmed via inspection of the unit.Unit was received with a worn hex bushing and the lock was still able to move after being locked down.This unit is beyond integra's 7 years recommended life cycle (manufactured in 2008).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 2000 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: 11369158
• MDR Text Key: 234229283
• Report Number: 3004608878-2021-00115
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K932807
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1