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

Catalog Number A10595

Device Problem Positioning Failure (1158)

Patient Problems Hematoma (1884); Skull Fracture (2077)

Event Date 03/10/2014

Event Type  Injury  

Event Description

The second report of two involving two different mayfield skull clamps.This report involved the skull clamp with the lot number 089.It was reported that a mayfield skull clamp (a1059) was involved in an injury to a child ((b)(6)) during a craniotomy for tumor removal.The course of events was described as follows; applied the first mayfield skull clamp (not known which one) to the pt.The registrar (physician) stated the torque screw was turned to 40 pounds and "it did not engage'.- asked what "did not engage" mean.Registrar stated 'can usually feel the torque knob going into the groove, and did not feel like this was happening." removed the first mayfield skull clamp and applied the second mayfield skull clamp (not known which one).Registrar stated "it didn't engage" again - not sure if this was at 40 pounds or not but, at this stage decided to remove second mayfield skull clamp.At this stage applied an infinity - a1114 skull clamp, lot #l135 and a1112, s/n (b)(4), lot 101.Was told they used skill pins with the infinity system -not gel pads.They configured the pins in opposite configuration to that used for the mayfield.Applied 2 skull pins on side where previously there had been one, and 1 skull pin on the side where previously there had been 2.Surgery then proceeded as per normal - removed the tumor.The injuries were not detected until a post procedure mri that occurs immediately after procedure was done.After the procedure for tumor removal which went ahead as expected without event, the pt was taken for a confirmatory mri as per the normal protocol after tumor removal.This is when the fracture and extradural hematoma were detected.The pt was treated conservatively with add'l scans to check on status of hematoma/fracture.Pt progressed as expected for tumor removal.No further events/complications reported as a result of fracture or hematoma.Is it unk whether the fracture was anywhere near the pins insertion.A stereotactic device was not used during this procedure.At this point integra has repeatedly asked which of the two units were involved first and then second.The hospital has not been able to tell us.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based upon the reported info.

• Brand Name: MAYFIELD MODIFIED SJULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 3780706
• MDR Text Key: 18795398
• Report Number: 3004608878-2014-00044
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A10595
• Device Lot Number: 089
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• 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
• Patient Age: 7 YR