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

Model Number A1059

Device Problem Naturally Worn (2988)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

A facility reported that there was an evidence of wear on the thread of the head which affects the moment of anchoring the mayfield modified skull clamp (a1059).The unit was used for a craniotomy procedure which was delayed for 20 to 30 minutes with no patient injury reported.The clinical team intervened making an inappropriate adjustment and the surgery was successfully completed without patient 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.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was not returned for evaluation after three good faith attempts (gfes) were made: device history record (dhr) review - lot number information has been provided; therefore, dhr was reviewed, and no anomalies were found.Failure analysis - based on customer provided photographs, the complaint is confirmed.There appears to be damage or wear at the opening of the starburst threads on the main clamp body.Root cause -the definite root cause cannot be identified as the device was not returned.Based on the reported complaint, probable root cause includes damage from improper assembly or mishandling.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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: 15433562
• MDR Text Key: 303668617
• Report Number: 3004608878-2022-00189
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: M268A10591
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2022
• Date Device Manufactured: 05/03/2022
• 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