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

Catalog Number A2114

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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

A facility reported that the knob on top of the mayfield infinity xr2 skull clamp (a2114) that allows it to expand does not hold it in place.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.

Manufacturer Narrative

Device history record: the dhr shows no abnormalities related to the reported failure.Mayfield infinity skull clamp (a2114) was returned for evaluation.The reported complaint was confirmed.The left and right pawls are worn and need replaced.Evaluation showed that the torque knob needs to be taken apart and thoroughly cleaned.Unit received without pedi rocker arm or suit case.The unit needs repair, and replacement of worn parts.General maintenance and cleaning required.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 11240745
• MDR Text Key: 233475947
• Report Number: 3004608878-2021-00034
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K130389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1