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

Model Number A1108

Device Problem Mechanics Altered (2984)

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

Event Type  malfunction  

Manufacturer Narrative

The mayfield triad skull clamp (a1108) was returned for evaluation: failure analysis: unit received with the lock having both rotational and lateral movement and a residue buildup was present.Upon disassembly, repair noted the index knob and the lock needed new components added to replace worn internal parts.Unit was machined to have heli-coils added to the large starburst threads.Root cause: complaint confirmed via inspection of the unit.The index knob was not locking properly.The index knob and lock required replacement of worn internal components due to routine use and wear.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2008).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

A facility reported that the mayfield skull clamp (a1108) was loosening once affixed to patient's skull.No patient injury or surgical delay was reported.

• Brand Name: MAYFIELD TRIAD 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
• 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: 13902819
• MDR Text Key: 287905105
• Report Number: 3004608878-2022-00053
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253518
• UDI-Public: 10381780253518
• 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
• Report Date: 03/25/2022

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 Model Number: A1108
• Device Catalogue Number: A1108
• Device Lot Number: 089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/25/2022
• 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