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

Model Number A1059

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the manufacturing process and final device inspection ensures that non-conforming product is not released into the distribution chain.Failure analysis - complaint confirmed via inspection of the unit.Unit received with the lock having movement, requiring replacement of worn internal parts.Unit received with the lock having rotational and lateral movement and a residue buildup was present.Unit received with an older model ratchet extension.General maintenance and cleaning performed and new components have been added to replace worn internal parts.Root cause - complaint confirmed via inspection of the unit.Unit received with the lock having movement, requiring replacement of worn internal parts.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2012).Probable root cause is routine use and wear.

Event Description

This is 1 of 2 reports linked to mfg report number 3004608878-2022-00102: a facility reported that the locking mechanism on the mayfield modified skull clamp (a1059) was not holding.The facility has not reported if there was patient involvement, injury or surgical delay relative to this event.

• Brand Name: MAYFIELD MODIFIED 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: 14453536
• MDR Text Key: 300331207
• Report Number: 3004608878-2022-00101
• 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
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Date Manufacturer Received: 04/25/2022
• 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