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

Catalog Number A1059

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

The customer stated they had another issue with the a1059 mayfield modified skull clamp and the patient was injured.There was no other information provided.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 history record reviewed for the unit(s) listed in this complaint under lot code: 129/099025.No abnormalities related to reported incident found nor were there any variances, mrr¿s or reworks associated with this lot/work order number.Service history: none on file.Trend analysis: no manufacturing or design related trend has been identified.Failure analysis: the returned unit has passed all specific functional testing requirements, except for the lock having rotational movement when unit is not under pressure.However, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have lost pressure or slipped.Conclusion: in summary, we are unable to confirm or duplicate the end users experience.The returned unit passed all functional testing requirements, however, general maintenance is required as this device was manufactured in 2012 with no prior service history.The mayfield patient positioning for success chart has been provided to the customer as a refresher tool.

• Brand Name: MAYFIELD MODIFIED 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: 6277857
• MDR Text Key: 65772023
• Report Number: 3004608878-2017-00019
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2012
• 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
• Patient Outcome(s): Other