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

Catalog Number A2000

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

The a2000 mayfield skull clamp was reported to be too loose.The head moves when clamp is on.The patient was prepped for surgery.It was unknown if there was any patient injury or medical intervention required.It was also unknown if the incident led to a delay or increase in the procedure.Additional information has been requested.

Manufacturer Narrative

Integra completed its internal investigation 02/13/2017.The investigation included: method: -dhr review - review of complaint management database for similar complaints.-visual evaluation.Dhr review: the device in question was manufactured on 09/30/2006.Service history: date of service: 9/10/2015.Date of service: 4/20/2015.Trend analysis: no manufacturing or design related trend has been identified.Failure analysis: unit received with the hex bushing is worn and the lock still moves after unit is locked down and needs to be replaced.Conclusion in summary, the root cause for this error is normal wear and tear from heavy use in the field.Service department and engineering analysis has concluded the returned unit should not have been put into surgery use in this condition, the pre surgery adjustments and checks should have detected this condition.Lastly general maintenance is required as this device was last service in 2015.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6265160
• MDR Text Key: 65666338
• Report Number: 3004608878-2017-00016
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

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: A2000
• Device Lot Number: 067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SKULL PINS