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

Catalog Number A1059

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

A facility reported that they needed a "broken" mayfield modified skull clamp (a1059) to be repaired/inspected due to an incident.Details of the incident,b injury or any surgical delay have not been provided.Additional information has been requested.

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

Additional information: initial report from facility stated "yes" to patient injury; however, no further details of the injury has been received despite our attempts to obtain same.Investigation findings: 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 unit showed that the unit had slight rotational and lateral movement in the lock, but when the clamp was properly positioned and put under pressure, it would not move.Since the unit was involved in a patient injury, it was sent to quality engineering (qe) for further investigation.Qe confirmed the findings of the service & repair report and noted wear on the starburst teeth.New components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The probable root cause is improper or suboptimal placement of the skull clamp on the patient.No further investigation is 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: 18628397
• MDR Text Key: 334473080
• Report Number: 3004608878-2024-00014
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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
• Date Manufacturer Received: 02/07/2024
• 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