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

Catalog Number A1059

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Skull Fracture (2077)

Event Type  Injury  

Event Description

The patient acquired a skull fracture.The surgeon did not think it was the mayfield's fault, but they would like to send in the clamp for evaluation to make sure the that the torque screw pressure gauge was accurate.Revision /medial intervention was required.There was no delay in surgery.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 01/12/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: with respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement, when unit is properly positioned and put under pressure unit would not have slipped.Unit needs heli-coils added to large starburst threads.The complaint on the accuracy of the torque screw pressure was tested to ensure proper poundage and no issues were observed.General maintenance and cleaning required.This device was manufactured on 08/26/2013 and a review of (b)(4).Service history: date of service: 02/10/2015.A review of complaints history revealed a total of four customer complaints were received including this case.No new design or manufacturing trends have been identified.In summary the device involved in this case was initially reported as "slippage/incident" upon receipt and inspection.The end users reason for return could not be confirmed or duplicated as the device in question passed all specific functional testing requirements including the accuracy of the torque screw pressure.General maintenance and cleaning 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5159737
• MDR Text Key: 28673591
• Report Number: 3004608878-2015-00276
• 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: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• 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; Required Intervention