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

Catalog Number A1059

Device Problem Mechanics Altered (2984)

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 during an unspecified surgery, the mayfield modified skull clamp (a1059) had a loose screw.No patient injury or surgical delay was reported.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

The mayfield modified skull clamp ((b)(4)) 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 customer description could not be confirmed.The locking mechanism requires a slightly low torque value to lock.For routine maintenance, the lock was opened and showed residue build up and dents underneath the swivel base.The internal parts to adjust the swivel lock assembly were replaced.Preventively, the plunger assembly which locks the ratchet extension was removed and cleaned.New components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - the complaint is not confirmed.The locking mechanism required a slightly low torque value to lock, and further inspection found that the clamp needed cleaning and replacement of worn parts due to routine use and wear of the clamp.No further investigation 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 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: 17666308
• MDR Text Key: 322448394
• Report Number: 3004608878-2023-00161
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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