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

Catalog Number A1059

Device Problem Retraction Problem (1536)

Patient Problems Laceration(s) (1946); Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the torque screw on the mayfield modified skull clamp (a1059) bounced back and the patient fell out of the skull clamp resulting in a head injury which required stitching.Additional information received indicates that the skull clamp was applied to the patient with a dens fracture with the patient positioned in prone position on the jackson spine table.When the neck was flexed, the skull clamp came loose and the mayfield device was tightened up to 3x in in the head, but each time the windings came back and therefore the head was not properly fixed.The patient was put back in the bed again; the parietal left side of the patient's head was damaged with severe bleeding.The surgeon placed 5 sutures and a new mayfield was applied and the patient was repositioned.The operation went well, but there was unnecessary skin damage to hairy head of the patient, and surgical delay of 45 minutes.

Manufacturer Narrative

The mayfield skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis - during assessment, a functional test was performed and the clamp was working fine, except for the locking mechanism having some movement.This issue would not have caused the described failure.The locking mechanism needed overhaul, worn parts needed replaced.Replaced needed parts, readjusted locking mechanism according to specifications.Unit was cleaned and passed 1101 functional test.Evaluation found no device deficiencies that would have contributed to the reported complaint.Root cause - the evaluation found no device deficiencies that would have contributed to the reported complaint.The potential root cause of the reported condition is likely improper placement of the skull pins on the skull clamp slots and/or improper placement of the skull clamp during use.The definite root cause cannot be reliably determined.No further investigation is required based on the acceptability of risk and no adverse trends are identified.This will be monitored and trended going forward.

• 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
• MDR Report Key: 11737968
• MDR Text Key: 248532595
• Report Number: 3004608878-2021-00312
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1