MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 11/08/2023

Event Type  Injury  

Event Description

A facility reported that during prone positioning for a craniotomy procedure, the mayfield composite series skull clamp (a3059) slipped.This resulted in a laceration approximately 2.5cm on the left temple area.The patient was returned to the stretcher, where the physician cleaned and stapled the laceration.Another physician was aware and observed the injury.A different mayfield head clamp was applied, and the patient was repositioned prone.Post-procedure, the laceration was cleaned and closed using sutures.

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10   the mayfield composite series skull clamp (a3059) 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 was unable to duplicate the reported complaint.However, unrelated to the reported issue, the unit had up and down movement in the lock and the teeth were grinding in the unlocked position.As a result, the disk ratchet and retainer were replaced.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.There was movement in the lock and the unit required replacement of worn components from routine use and wear.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: 18241455
• MDR Text Key: 329429917
• Report Number: 3004608878-2023-00221
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• 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,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• 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