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

Model Number A1114

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Mayfield infinity skull clamp (a1114) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: unit received with the lock having rotational and lateral movement and a residue buildup was present.Unit had new components added to replace worn internal parts.General maintenance and cleaning was performed.Root cause: complaint confirmed via inspection of the unit.Unit received with the lock having rotational and lateral movement, requiring replacement of internal parts worn as a result of wear and tear.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

This is 1 of 2 reports linked to mfg report number 3004608878-2021-00598: a facility reported that the locking mechanism of the mayfield infinity skull clamp (a1114) was not working properly.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

• Brand Name: MAYFIELD INFINITY 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: 12632264
• MDR Text Key: 276390581
• Report Number: 3004608878-2021-00597
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1114
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2018
• 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