MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number A2114

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 01/08/2019

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.Linked to mfg report number: 3004608878-2019-00018.

Event Description

This is 2 of 2 reports.A sales representative reported on behalf of the physician that they have been experiencing movement of the xr2 unit (a2114 mayfield infinity xr2 skull clamp and a2079 mayfield infinity xr2 base unit) during surgical procedures.The movement was affecting the accuracy of the navigation system.Additional information received on (b)(6), (b)(6), and (b)(6) 2019 indicating that the (b)(6) year old male patient was pinned on the xr2 system.An o-arm spin was completed for navigation and the patient was prepped for surgery.When final checking the security of the system, a slight drop was seen and felt.Navigation was immediately checked and accuracy was off.The patient was un-pinned and placed with a regular mayfield.An intra-operative o-arm computed tomography (ct) was taken.There was a 30-minute delay in surgery.There was no patient adverse consequence due to surgery delay.It was reported that this was the second time it happened on this item.

Manufacturer Narrative

The product was not sent in to the manufacturer for evaluation.Device history record reviewed revealed no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr¿s, variances or rework.The complaint was not confirmed.The root cause to the end user's experience could not be completed.Device identifier (b)(4).

Event Description

N/a.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 8290610
• MDR Text Key: 134594736
• Report Number: 3004608878-2019-00019
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K090506
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A2079 BASE UNIT; NAVIGATION SYSTEM
• Patient Age: 78 YR