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

Catalog Number A1114

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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

This is 1 of 2 reports linked to mfg report number 3004608878-2021-00155: a facility reported that during brain tumor surgery performed by trephination, the screws of the mayfield skull clamp (a1114) were loose; therefore, the rocker arm did not lock.A replacement mayfield skull clamp was used and the patient required new holes for the mayfield skull pins, as the new skull clamp was bigger.The event led to an increased surgery time of 1 hour with no further patient impact.The event occurred in february 2021, but the exact date is unknown.

Manufacturer Narrative

The mayfield skull clamp (a1114) was received for evaluation: service history review: a review of the service history records for the involved unit shows that the unit was returned twice (11/2020, 1/2021) for overhaul repair.The reported complaint was confirmed from the evaluation.Evaluation showed that the ball/spring plunger are loosen.Additionally, the unit was delivered only with a child rocker arm.The unit needs repair, pm and replacement of worn parts which was performed.General cleaning and maintenance also 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 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
• MDR Report Key: 11414873
• MDR Text Key: 243909007
• Report Number: 3004608878-2021-00153
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Device Lot Number: CD00015_298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR