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

Model Number A1059

Device Problem Mechanics Altered (2984)

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

Event Type  malfunction  

Manufacturer Narrative

Mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Evaluation found the 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 needs to be machined to have heli-coils added to the large starburst threads, and the set screw in the swivel base was tight.Replacement of worn components and addition of heli-coils, general maintenance and cleaning performed.Root cause - complaint confirmed via inspection of the unit.The lock had rotational and lateral movement and the index knob and lock required replacement of worn internal parts.Probable root cause is routine use and wear.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 during an inspection, the lock on the mayfield modified skull clamp (a1059) was very loose and gave no resistance.There was no patient involvement.

• 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: 13902833
• MDR Text Key: 287912446
• Report Number: 3004608878-2022-00055
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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
• Device Lot Number: 144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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