MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problems Decrease in Pressure (1490); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

This is the first of two reports (same product id, same product problem, same facility, different patients).This report is in regards to the first patient.Linked to mfg report: 3004608878-2016-00239.The a3059 mayfield composite series skull clamp lost pressure before a surgical case was started.The (b)(6) female patient was prepped for surgery.The device was repositioned on her head and stayed in place throughout the case.There was no patient injury or death and no revision or medical intervention was required.The product problem caused a 30 minute delay in surgery time.

Manufacturer Narrative

Integra has completed their internal investigation on 30 sep 2016.The investigation included: method: on site observation of device in use.Dhr review.Review of complaint management database for similar complaints.Results: an on site visit was conducted at the user facility to inspect the device, observe the device in use and obtain feedback from the medical team.Device history record reviewed for this product id work order# (b)(4) manufactured on 23-dec-2010 show no abnormalities related to the reported failure.The (b)(4) devices manufactured under this work order passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.A two year lookback in (b)(6) for this reported failure and or related to "lost pressure" for this product id shows that no additional complaints were received outside of this complaint and another complaint.Both complaints were filed by the same customer on the same date.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: the ils team was unable to confirm the complaint.Based on the equipment inspected and the surgical cases observed, all devices functioned as intended without incident.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: 5917140
• MDR Text Key: 54344391
• Report Number: 3004608878-2016-00238
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2010
• 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
• Patient Age: 32 YR