MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A2000

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

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 numbers: 3004608878-2019-00135, 3004608878-2019-00137, 3004608878-2019-00138.

Event Description

This is 2 of 4 reports.A distributor reported that the a2000 mayfield 2000 skull clamp wiggled and was not stable during the pin fixation.Additional information received on 11june2019 : the device was not in contact with the patient; hence there was no patient injury.It was unknown if there was a patient prepped for surgery or if medical intervention was required.

Manufacturer Narrative

The device history record review showed no abnormalities related to the reported incident nor were there any variances, mrr¿s or reworks associated with this lot/work order number.No service history on file.The device was manufactured in 2012.The device was not released for evaluation therefore the failure analysis to identify root cause to the end users' experience could not be determined.

Event Description

N/a.

• Brand Name: MAYFIELD 2000 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: 8699293
• MDR Text Key: 148013092
• Report Number: 3004608878-2019-00136
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K932807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A2000
• Device Lot Number: 127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1