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

Model Number A1059

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

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: unit received with the lock having rotational and lateral movement and a residue buildup was present.The unit was received without the plunger cap.New components were added to replace worn internal parts.General maintenance and cleaning were performed.Missing parts and worn parts were replaced.Root cause analysis: complaint confirmed via inspection of the unit.The unit was received without the plunger cap.The lock had movement and required replacement of worn internal parts from routine wear and tear.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

A facility reported that the threaded cap on mayfield modified skull clamp (a1059 ) was missing.It is unknown if there was patient involvement however; no patient injury or surgical delay has been reported.After the device was returned by the customer, evaluation showed that the lock has rotational and lateral movement.

• 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: 12846375
• MDR Text Key: 283790757
• Report Number: 3004608878-2021-00642
• 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
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• 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