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

Catalog Number A3059

Device Problem Unstable (1667)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the mayfield composite series skull clamp (a3059) was loose between the 2 pins, and the patient's head fell during surgery.Additional information has been requested.

Manufacturer Narrative

The mayfield 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 reported complaint was confirmed from the evaluation: there was rotational movement and a residue buildup present in the swivel lock assembly.To resolve all issues, the internal parts to adjust the unit to manufacturer specifications were replaced and the swivel lock assembly was cleaned.After completing the reassembly, a function test was successfully performed.Root cause - the complaint is confirmed via inspection of the unit.The unit required replacement of worn internal parts and cleaning due to routine use and wear.Additionally, improper or suboptimal placement of the skull clamp can contribute to movement or slippage of the patient¿s head.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.

• 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: 18504404
• MDR Text Key: 333316102
• Report Number: 3004608878-2024-00007
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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
• Patient Sex: Female