MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number A1059

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

A facility reported that the mayfield modified skull clamp (a1059) was not holding pressure.No information has been provided on patient involvement, injury, or surgical delay.

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

N/a.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The device passed all specific functional testing requirements except for slight movement in the lock.Despite the movement, when the clamp is properly positioned and in the locked position, it would not move.New components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - complaint not confirmed.Probable root cause is improper or suboptimal setup/placement of the skull 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: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• 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: 17191141
• MDR Text Key: 317753624
• Report Number: 3004608878-2023-00117
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• 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
• Device Lot Number: 174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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