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

Catalog Number A1059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/09/2021

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 patient slipped while being supported by the mayfield base unit and the mayfield modified skull clamp (a1059).The mayfield was placed on patient in supine position for a posterior cervical fusion, and when the patient was turned prone they heard a pop as the skull clamp was being attached to the bed adaptor.They noted a scalp laceration which was stapled to close.Another skull clamp was used to complete the procedure.There was a 20 minute surgery delay with no adverse consequences to the patient.Patient was doing fine after the procedure.

Manufacturer Narrative

Device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.A1059 mayfield modified skull clamp was returned for evaluation.The functional testing and the evaluation of the device could not duplicate the reported complaint.When the unit is properly positioned and put under pressure unit would not have slipped.Preventive maintenance and cleaning required at this time.This device exceeds its expected life of 7 years.It is highly recommended that the device be replaced with a new one.Please refer to the device ifu for proper usage instructions.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.

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
• MDR Report Key: 11845367
• MDR Text Key: 251465025
• Report Number: 3004608878-2021-00364
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/30/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1