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 Laceration(s) (1946)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

The 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 - investigation of the returned unit showed that the lock was loose, had rotational and lateral movement and a residue buildup was present.The unit had not been serviced since 2019 per service & repair records.Unit was also sent to quality engineering for investigation due to an injury to the patient.Further investigation by quality engineering confirms the findings of the service & repair report (the lock was loose and the unit was received in worn condition).New components were added to replace worn internal parts and general maintenance and cleaning were performed.Root cause - the reported complaint was confirmed via inspection of the unit.Probable root cause is routine use/wear and lack of preventive maintenance.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

A facility reported that during a posterior cervical fusion procedure, the lock was released on the mayfield modified skull clamp (a1059) causing a cut at the back of the patient's head (left side).The surgeon sutured the site before proceeding to prep for the primary surgical procedure.The patient is recovering at this time from the surgical procedure and there is no negative reporting regarding the cut from the pins.No information on surgical delay/increased surgery time was reported.

• 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: 17007035
• MDR Text Key: 315994577
• Report Number: 3004608878-2023-00091
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Device Lot Number: 149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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