MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA POOL - MAYFIELD 2 SERIES SKULL CLAMP; MAYFIELD COMPOSITE SERIES

Catalog Number A3059P

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

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

This is 1 of 2 reports linked to mfg report number 3004608878-2023-00223: a facility reported that the mayfield 2 series skull clamp loaner(a3059) and customer's mayfield composite series skull clamp (a3059) were used for a posterior cranial procedure.The surgeon felt that both devices had too much movement or flex when the patient's head was in the device.They then changed to a horseshoe headrest with tape and continued with the procedure.There was surgical delay of 30 minutes; however, there was no injury.

Manufacturer Narrative

The pool - mayfield 2 series skull clamp (a3059p) was not returned for evaluation; therefore, an evaluation of the device could not be performed and the definite root cause cannot be identified.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Based on the reported complaint, probable root cause is improper or suboptimal placement of the skull clamp on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: POOL - MAYFIELD 2 SERIES SKULL CLAMP
• Type of Device: MAYFIELD 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: 18239823
• MDR Text Key: 329395384
• Report Number: 3004608878-2023-00222
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• 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: 01/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/19/2024
• Date Device Manufactured: 08/13/2015
• 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
• Treatment: MAYFIELD SKULL CLAMP (A3059).
• Patient Outcome(s): Death
• Patient Sex: Female