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

Catalog Number A1108

Device Problem Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An integra territory manager reported on behalf of the customer that on an unknown procedure on (b)(6) 2019, the patient was being moved from supine to prone position and the surgeon felt and heard a clunk by the rocker of the a1108 mayfield triad skull clamp as they were rotating the patient.There was no patient injury reported.An additional information was received on 18sept2019, stating that the patient undergone a posterior cervical laminectomy.There was a 15 minute delay in surgery noted due to repositioning of the mayfield headrest clamp to patient's head.The procedure was completed using the same mayfield.An integra a1047 re-usable mayfield pins were also used during this case.

Manufacturer Narrative

An additional information was received on 01oct2019 indicating that the patient was prepared for surgery but was not prepped with antiseptic solution as the staff were in the process of positioning the patient.The device was used for a posterior cervical laminectomy / discectomy procedure.The patient was initially positioned supine as monitors were connected and while the patient was intubated.Once anesthesia was ready for the surgical team to position the patient in the prone position, the surgeon began to pin the skull and attach the mayfield.Once the mayfield was on and as they were turning/rotating the patient to prone, a "klunk" was heard and the surgeon mentioned feeling the klunk (as in the patients head ¿dropping¿ slightly).The staff nurse heard the klunk and reported that she was not able to actually see the patient's head drop.The surgeon removed the mayfield and pins and re-pinned or repositioned with the other mayfield device.

Event Description

N/a.

• Brand Name: MAYFIELD TRIAD 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: 9134447
• MDR Text Key: 189743958
• Report Number: 3004608878-2019-01018
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1108
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A1047 RE-USABLE MAYFIELD PINS