MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; N/A

Catalog Number A1059

Device Problems Mechanics Altered (2984); Physical Resistance/Sticking (4012)

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 the ratchet arm on the mayfield modified skull clamp (a1059) was stuck, not moving smoothly, and the swivel lock was very loose.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

Event Description

N/a.

Manufacturer Narrative

Mayfield modified skull clamp (a1059) was returned for evaluation.Failure analysis: unit received with the lock having rotational and lateral movement and a residue buildup was present.The starbursts were within tolerances.New components were added to replace worn internal parts and general maintenance performed.Root cause analysis: complaint confirmed via inspection of the unit.Unit received with the lock having rotational and lateral movement, requiring replacement of worn internal parts.The starbursts were found to be within tolerances.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.Unit is beyond integra's 7 years recommended life cycle (manufactured in 2009).

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: N/A
• 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: 12556671
• MDR Text Key: 274104314
• Report Number: 3004608878-2021-00577
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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: 11/09/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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