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

Catalog Number A1059

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

Integra has completed their internal investigation on december 08, 2017.Failure analysis: with respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement when unit is not under pressure, this would not have caused a slippage.When unit is properly positioned and put under pressure unit would not have slipped.General maintenance and cleaning required.Device history review: unit was made in 2000, which is well beyond integra's 7-year warranty period, also this product was not serialized back in that time frame.Dhr review can not be performed at this time as no serial number was originally assigned.Unit has not been sent in for maintenance since 2008.Trend analysis: no manufacturing or design related issues were confirmed.Root cause is undetermined at this time.Complaint not confirmed.

Event Description

On (b)(6) 2017, while positioning the patient¿s head, the mayfield modified skull clamp did not properly lock and a patient injury occurred.The patient was a (b)(6) year-old male.An unspecified revision/medical intervention was required.There was no delay in surgery reported.Additional request for information has been sent.

• 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: 7101044
• MDR Text Key: 94279797
• Report Number: 3004608878-2017-00323
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• 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: 11/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 65 YR