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

Catalog Number A1059

Device Problems Device Slipped (1584); Unstable (1667)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

The a1059 mayfield skull clamp caused a laceration.It was in use during a posterior cranial fossa surgery.The patient was in prone position with the skull clamp in place when the head moved.The staff managed to complete the surgery but at the end of the surgery they discovered a wound [laceration] on the head due to the pin of the mayfield.The screw was unscrewed and the patient now had a laceration on the head.Suture stitches were used to treat the wound.

Manufacturer Narrative

Integra has completed their internal investigation on 09jan2017.The investigation included: methods: -evaluation of actual device.-review of device history records.-review of complaint history.Results: the evaluation verified customer information as valid.During investigation it was observed that unit is in a very bad condition.The teeth of the base are worn off, the surface coating of ratchet extension and swivel base is defect and the rocker arm pin holders diameters are too big; this leads to the possibility of moving skull pins.The device in question was manufactured on june 30, 2008.For this individual item number no history available no trend has been identified.No manufacturing or design related trend has been identified.Conclusion: in summary the end users reason for return was verified however the root cause could not be conclusively be determined.This issue is being monitored.General maintenance is required as this device was manufactured in 2008 with no prior service history.

• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6149772
• MDR Text Key: 61601568
• Report Number: 3004608878-2016-00337
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2008
• 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): Required Intervention