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

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.Linked to mfg report number 3004608878-2020-00657.

Event Description

This is 2 of 2 reports.A biomedical technician reported a failure on the locking mechanism on both of the clamps of the mayfield skull clamp.There was no known injury or surgical delay.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.The reported complaint was confirmed from the evaluation of the returned mayfield skull clamp.The lock has rotational and lateral movement and a residue buildup is present.General pm is required and worn parts needs to be replaced.The observed condition is likely caused by improper handling/ wear and tear.The definite root cause cannot be reliably determined.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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 45227
• MDR Report Key: 10820217
• MDR Text Key: 216945173
• Report Number: 3004608878-2020-00658
• Device Sequence Number: 1
• Product Code: HBL
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1