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

Catalog Number A1059

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the locking mechanism on the a1059 mayfield skull clamp failed, resulting in the patient falling forward in pins.The patient was a (b)(6) year female who was reported to have a revision or medical intervention.There was a 15-minute delay in surgery.Additional information request was sent.

Manufacturer Narrative

Investigation completed 07/17/2017.Device history record reviewed for sn (b)(4) work order /098471 lot/ 131 manufactured on 3/14/2013 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points except for rejected product labels which were replaced.Previous service history sr # (b)(4).No manufacturing or design related trend has been identified.Root case is undetermined at this time.The unit was set up and tested, it was noted the lock has rotational movement when unit is not under pressure, however, this would not have caused a slippage.When unit is properly positioned and put under pressure, unit did not slip.Unit was last repaired on and will require pm maintenance preformed at this time.

• 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: 6673492
• MDR Text Key: 78595227
• Report Number: 3004608878-2017-00202
• 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
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• 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: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2013
• 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
• Patient Age: 29 YR