MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRIAD SKULL CLAMP

Catalog Number A1108

Device Problems Device Slipped (1584); Unstable (1667); Fitting Problem (2183)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is the first of two reports (same product id, same user facility and doctor, same product problem, different patients).This report is in regards to the first patient.Linked to mfr report: 3004608878-2016-00291.The a1108 mayfield triad skull clamp does not tighten and has slipped two times (2x).There were two separate incidents.Both happened prior to placement on the patient.They were on separate days and there were no patient injuries to report.The clamp had just been repaired.Additional information was requested.

Manufacturer Narrative

Integra completed its internal investigation 11/17/2016.The investigation included: method: dhr review; trend analysis; device evaluation.Results: the device in question was manufactured on september 30, 2004.No manufacturing or design related trend has been identified.The returned unit passed all specific functional testing requirements.When unit is properly positioned and put under pressure unit would not have slipped.Conclusion: in summary, we are unable to confirm or duplicate the end users experience.The returned unit passed all functional testing requirements.The mayfield patient positioning for success chart has been provided to the customer as a refresher tool.

• Brand Name: MAYFIELD TRIAD SKULL CLAMP
• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6063670
• MDR Text Key: 59032302
• Report Number: 3004608878-2016-00290
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2004
• 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