MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problems Unintended System Motion (1430); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 09/26/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a (b)(6) female was involved in an incident with the mayfield modified skull clamp.The patient was prepped for surgery.The swivel lock of the skull clamp was in the locked position, but it still moved and injured the patient.An unspecified revision/medical intervention was required.There was a delay in surgery due to product problem for 10 minutes.Request for additional information was sent.

Manufacturer Narrative

Investigation completed 10./17/2017.With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement when unit is not under pressure, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have slipped.General maintenance and cleaning required.Device history record reviewed for sn (b)(4) work order /(b)(4) lot/ 154 a total of (b)(4)were manufactured on 5/20/2015 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points.No manufacturing or design related trend has been identified.Root cause is undetermined at this time.Complaint not confirmed.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6941456
• MDR Text Key: 89229082
• Report Number: 3004608878-2017-00292
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR