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

Catalog Number A3059

Device Problem Unstable (1667)

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

Event Type  malfunction  

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 there was no more stability on the mayfield swivel adaptor (a3059), and neuro-navigation was not possible.The device was in contact with the patient; however there was no patient injury.The event led to increased surgery time of 1 hour.

Manufacturer Narrative

The mayfield skull clamp was received for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.The reported complaint was confirmed from the evaluation.The investigation showed that the skull clamp is hard to adjust.Some part of the device are worn and the unit is dirty.The unit needs repair, preventative maintenance and replacement of worn parts along with general cleaning.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 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
• MDR Report Key: 11477669
• MDR Text Key: 243915804
• Report Number: 3004608878-2021-00178
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Device Lot Number: SS193526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1