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

Catalog Number A1059

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that a a1059 mayfield modified skull clamp was used on a patient in an unspecified procedure.The date of the incident was unknown.It was stated that the room staff "flipped" the patient to prone when the mayfield came apart.The patient's head was already in pins.Additional information received on 12nov2018 indicated that they had to use a different skull clamp to finish the case.The device was in contact with the patient but no injuries were reported.It is unknown if there was any surgery delay caused by the malfunction.Additional information has been requested.

Manufacturer Narrative

The device was returned for evaluation.With respect to the returned unit, it has passed all specific functional testing requirements, except for the lock having rotational movement.However, when unit is not under pressure, this would not have caused a slippage.When unit is properly positioned and put under pressure, device would not have slipped.This device exceeds its expected life of 7 years.Complaint is not confirmed.The root cause is unknown.However, review of the foreseeable sequence of events indicated in risk management file indicates the most likely reason for reported failure of "unintended movement of the patient¿s head¿ is: clinician or staff applied an inadequate load to the patient¿s head; clinician used unapproved skull pins; index locking mechanism was not fully engaged; clinician/staff applied a clamping load greater than the patient¿s skull could support.

• 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 45227
• MDR Report Key: 8077661
• MDR Text Key: 128414399
• Report Number: 3004608878-2018-00263
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1