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

Catalog Number A3059

Device Problem Ejection Problem (4009)

Patient Problem Laceration(s) (1946)

Event Date 10/08/2021

Event Type  Injury  

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 mayfield skull clamp (a3059) slipped and caused a small laceration to a patient's temple.Mayfield head pins were appropriately secured to skull at 60 pounds of pressure using the tightening screws.The patient turned prone for surgery and in the process of attaching the mayfield to the bed and positioning his neck for surgery, the mayfield disengaged and popped open causing the appropriate pressure of the head pins to release 20 pounds.Patient suffered a small laceration on right side of the head where pins slipped.Additional information has been requested regarding patient outcome and surgical delay.

Event Description

N/a.

Manufacturer Narrative

Mayfield composite series skull clamp(a3059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: evaluation of the unit showed that it passed all specific functional testing requirements except for the lock having rotational movement when unit is not under pressure.This would not have caused a slippage.When the unit is properly positioned and put under pressure, the unit would not have slipped.There is no service history on this skull clamp.General maintenance and cleaning required at this time.Root cause analysis: evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs team could not duplicate slippage.Probable root cause for the reported complaint is improper positioning of the skull clamp.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 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12751862
• MDR Text Key: 280136074
• Report Number: 3004608878-2021-00627
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male