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

Catalog Number A1114

Device Problems Mechanical Problem (1384); Material Separation (1562); Naturally Worn (2988)

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

Event Type  malfunction  

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

A customer reported that the triad rocker arm attachment of the a1114 mayfield infinity skull clamp started to separate when pressure was added during the placement process leading to the locking knob being unable to unlock.It was also reported that the starbursts were worn down.There was no known patient injury or delay in surgery.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The device history record (dhr) showed no abnormalities related to the reported failure.The device passed all required dimension check and inspection points with no associated mrr¿s, variances or rework.The evaluation showed that the triad rocker arm was functioning properly when pressure was added.The observed condition is likely caused by wear and tear or improperly handling of the device.The definite root cause cannot be reliably determined.The reported compliant was not confirmed from the evaluation.No issues observed from the evaluation.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: MAYFIELD INFINITY 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: 10239497
• MDR Text Key: 197918152
• Report Number: 3004608878-2020-00348
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1