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

Catalog Number A1059

Device Problem Material Torqued (2980)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported information.

Event Description

The torque screw pressure indicator pin did not respond when the mayfield was applied to patient's head, resulting in significant patient injury.Extent of patient injury was not discussed.Asked customer to hold onto the specific torque screw.All signs indicate that the spring within the torque screw broke.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 9/29/2015.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: this device was manufactured on december 31, 2011.A dhr review of the following work orders with lot code 119 shows that the following lots passed all necessary inspection points without any mrrs, reworks or variances service history: date of service:11/14/2012, reason for repair:routine maintenance; date of service:5/19/2014, reason for repair: routine maintenance.No manufacturing or design related trend has been identified.Conclusion: the returned device was received for routine maintenance and not as a complaint therefore the root cause to the end users reason for return cannot be determined.This device was serviced and after maintenance the unit in question passed standard inspection and the torque registered properly.

• 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: 5048533
• MDR Text Key: 24769208
• Report Number: 3004608878-2015-00229
• 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: Nurse
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• 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: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2011
• 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 Outcome(s): Other