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

Catalog Number A3059

Device Problem Break (1069)

Patient Problems Hyperextension (4523); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

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

Medwatch report was received with the following information: "the patient was brought to the operating room for a posterior cervical surgery with decompression and fusion of the cervical spine due to severe spinal cord compression and myelomalacia.The patient was intubated by anesthesia.The surgeon had placed a mayfield clamp on the patient's head and the patient was turned prone onto the surgical table.As the mayfield clamp was attached to the table mount, the mechanism on the mayfield clamp broke and resulted in a hyperextension position which the surgeon quickly reduced into a flexion position.The patient's head was manually held by the surgeon while the mayfield clamp was removed.Afterwards the patient was turned to supine and back onto the gurney and a cervical collar was placed on the patient.The surgery was cancelled.The patient was woken from anesthesia, his neurological status was assessed and no spinal cord injury was incurred.The surgery was rescheduled." additional information was received as follows: "the initial procedure was attempted on (b)(6) 2023; was cancelled and then performed on (b)(6) 2023.".

Manufacturer Narrative

Medwatch #mw5147852 was received on15dec2023 with the following information: "the pt was brought to the operating room for a posterior cervical surgery with decompression and fusion of the cervical spine due to severe spinal cord compression and myelomalacia.The pt was intubated by anesthesia.The surgeon had placed a mayfield clamp on the pt's head and the pt was turned prone onto the surgical table.As the mayfield clamp was attached to the table mount, the mechanism on the mayfield clamp broke and resulted in a hyperextension position which the surgeon quickly reduced into a flexion position.The pt's head was manually held by the surgeon while the mayfield clamp was removed.Afterwards the pt was turned to supine and back onto the gurney and a cervical collar was placed on the pt.The surgery was cancelled, the pt was woken from anesthesia, his neurological status was assessed and no spinal cord injury was incurred.The surgery was rescheduled.Cervical disc disorder with myelopathy and c3/4 anterolisthesis with spinal cord compression.Pt admitted for posterior cervical decompression and fusion.".Clarifying information was also received via phone conversation with the risk manager on 1/12/2024: there was no spinal cord injury or any other injury to the patient.Patient was hyperextended when device broke, but this caused no sequelae.The indication for use of the mayfield device was "intervertebral compression or protrusion".

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10.Additional information received from the customer indicating the following: "as stated in the medwatch event description, there was hyperextension position which occurred during the mayfield device failure.Regarding the injury and patients history, i refer you back to the medwatch which provides the information you are seeking." investigation findings: the mayfield composite series skull clamp (a3059) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and shows no abnormalities related to the reported failure.The definite root cause cannot be identified as the device was not returned.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.

Event Description

N/a.

• 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: 18284154
• MDR Text Key: 330250233
• Report Number: 3004608878-2023-00227
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Date Device Manufactured: 04/06/2016
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White