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 Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  malfunction  

Event Description

This is the second of two complaints.(similar incident, different product id).During a neuro monitoring case, a (b)(6) -year-old male patient moved forward after being stimulated.There was no patient injury or death alleged.No revision or medical intervention required, and no delay in surgery reported.Request for additional information has been sent.Linked to mfg report number:3004608878-2017-00271.

Manufacturer Narrative

Integra has completed their internal investigation on october 24, 2017.Failure analysis - complaint not confirmed - no issues observed.With respect to the returned unit it has passed all specific functional testing requirements.Device history record: lot/ 154 a total of (b)(4) were manufactured on 6/28/2015 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points.No manufacturing or design related trend has been identified.Post market information will continue to be monitored.Root cause analysis - is undetermined at this time.The complaint issue is not confirmed.With respect to the returned unit it has passed all specific functional testing requirements.When unit is properly positioned and put under pressure the unit functioned properly.The unit needs heli-coils added to the large starburst threads.This issue however, would not have caused movement.General maintenance and cleaning is required.

• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6867968
• MDR Text Key: 87327295
• Report Number: 3004608878-2017-00272
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2015
• 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: 75 YR