MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; N/A

Catalog Number A1059

Device Problem Device Slipped (1584)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

A facility reported that during "c3-7 removal of instrumentation, c3-t2 posterior decompression with durotomy repair and neuro monitoring" on a patient, the mayfield modified skull clamp (a1059) slipped.The device was in contact with the patient,but there was no injury.There was a 10 minute surgery delay as the surgeon had to reposition the patient's head after starting the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

  the mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - investigation of the returned unit showed that the lock had rotational and lateral movement and a residue buildup was present.The starburst teeth were worn down, so the base casting was replaced.The index knob was revised to the current edition, and new components were added to replace worn internal parts along with general cleaning and maintenance.Root cause - the complaint could not be confirmed regarding the slippage, but the complaint on the starburst teeth is confirmed.Probable root cause is routine use and wear.Additionally, improper or suboptimal placement of the skull clamp can lead to movement of slippage of the patient.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: N/A
• 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: 17751405
• MDR Text Key: 324051600
• Report Number: 3004608878-2023-00167
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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